In 2026 Nara Organics sold its formula as a “European-made” product, manufactured in Germany. But the milk inside those cans started on California dairy farms. It was the same organic milk, from the same supplier, dried by the same cooperative, that FDA tied to the ByHeart infant botulism outbreak in November 2025.

That is the story of the second infant formula botulism outbreak in seven months. It is a supply chain that crossed an ocean twice and passed through six companies before it reached a baby’s bottle. Below, I walk through each link in that chain, what FDA has found so far, and what is still unanswered.
 
The outbreak
 
Four infants in California, Pennsylvania and Washington were hospitalized with type A infant botulism after drinking Nara Organics Whole Milk Organic Powdered Infant Formula. All four fell ill in April and May 2026, all four were boys under five months old, and all four were treated with BabyBIG.
 
FDA and CDC contacted Nara late on Friday, June 12. Nara recalled every lot the next day, calling it a step taken “out of an abundance of caution.” On July 6, FDA reported that an opened can of Nara formula from one sick baby’s home tested positive for Clostridium botulinum.
 
On August 27, FDA declared the outbreak over and released its key supply chain finding. The Nara lots linked to the illnesses were made with milk from Organic West Milk Inc. and spray dried by Dairy Farmers of America — the same two suppliers behind the ByHeart botulism outbreak. Whole genome sequencing also matched an infant who drank Nara formula to the ByHeart outbreak. FDA concluded that the two outbreaks share a common source of contamination.
 
The ByHeart outbreak
 
Nara was the second infant botulism outbreak. The first, linked to ByHeart Whole Nutrition infant formula, was far larger. When CDC declared it over on February 26, 2026, it counted 48 infants with infant botulism — 28 confirmed and 20 probable — in 17 states. All 48 were hospitalized. No deaths were reported.
 
California’s Infant Botulism Treatment and Prevention Program spotted the problem in early November 2025, after an unusual rise in cases among babies fed ByHeart. ByHeart first recalled two lots, then every ByHeart product days later. Because illnesses traced back as far as December 2023, CDC widened its case definition to cover any infant with botulism exposed to ByHeart since the formula launched in March 2022.
 
Testing found C. botulinum in opened and sealed ByHeart cans, in ByHeart’s base powder, and in organic whole milk powder. FDA identified 17 different strains of the bacteria across patients, product and ingredients. The milk powder came from Organic West Milk and was dried at Dairy Farmers of America’s plant in Fallon, Nevada, where FDA itself collected two matching isolates.
 
The link between Nara and ByHeart
 
FDA has tied the two outbreaks together in three ways.

1. Same milk. The Nara lots linked to illness were made with organic whole milk from Organic West, ByHeart’s milk supplier.
2. Same dryer. That milk was spray dried by Dairy Farmers of America, the same processor that dried ByHeart’s milk powder.
3. Same bacteria. Whole genome sequencing matched a Nara baby’s C. botulinum to bacteria from a ByHeart baby, from ByHeart’s base powder and from sealed ByHeart cans.

From that evidence, FDA concluded that the two outbreaks share a common source of contamination. Put plainly, it appears to be one contamination problem in one supply of organic whole milk powder, sold under two brands. ByHeart’s babies got sick first; Nara’s babies got sick after ByHeart’s recall, because no one had connected Organic West’s milk and Dairy Farmers of America to Nara’s formula.

The common thread is whole milk. Many U.S. infant formulas are built on skim milk with added plant oils. ByHeart and Nara both broke from that model, and both sold parents on whole milk as the reason to pay a premium. That selling point is exactly where the two outbreaks meet: organic whole milk powder was the ingredient they shared, and it is where FDA found C. botulinum. Brands built on that ingredient had every reason to test it for spores.

ByHeart sent its customers to Nara

The connection is not only on paper. When ByHeart recalled all of its formula in November 2025, it pointed its customers to Nara. A November 11, 2025 ByHeart Instagram post recommended Nara products and offered a 20 percent discount code to help families make the switch. ByHeart deleted the post in June 2026, after Healthbeat asked about it, saying it removed the post for safety reasons following the Nara news.

ByHeart says the two companies have no corporate, financial, contractual or manufacturing relationship. But parents who followed ByHeart’s advice moved their babies from one whole milk formula to another that, FDA later found, was made with milk from the same suppliers. The ByHeart recall took one brand off the shelves. It did not take that milk out of the formula supply.

From California dairy to Nara can

Piecing together FDA’s findings, U.S. Customs records and reporting by Food Safety News, eFoodAlert and the Associated Press, the milk traveled this route:

Nara Organics formula supply chain · farm to infant

The milk crossed the Atlantic as powder, became formula in Germany, was canned in Denmark, and came back to the United States under the Nara label. One link — how the powder got from DFA to Elb-Milch, and who sold it — has not been made public.

The branch to ByHeart matters. In January 2026, the AP reported that the organic whole milk powder that tested positive in the ByHeart outbreak came from Organic West milk dried at DFA’s plant in Fallon, Nevada. FDA’s Nara findings name the same two companies. C. botulinum spores survive pasteurization, so contamination that enters at the milk or drying stage can ride all the way into the finished can.

The incomplete customer list

The most troubling fact in FDA’s report is this. During the ByHeart investigation in late 2025, FDA ran a traceforward to learn whether Organic West sold milk to any other powdered infant formula maker. According to FDA, Organic West gave the agency an incomplete customer list — one that did not show its milk was going to the manufacturer of Nara’s formula.

In January 2026, an owner of Organic West told the Associated Press that the company had not sold organic whole milk powder to any infant formula maker other than ByHeart.

Meanwhile, Nara kept importing formula made with that milk. U.S. Customs records show shipments from Elb-Milch through April 30, 2026. The four Nara babies got sick in April and May. Had FDA known in late 2025 that Organic West’s milk was also going into Nara cans, those babies might never have been exposed.

Nara should have asked

Organic West’s list was not the only safeguard that failed. Nara had its own reasons to ask hard questions, and months to ask them.

ByHeart was Nara’s closest competitor: a premium organic whole milk formula sold to the same parents. When ByHeart recalled every can in November 2025, and FDA traced the problem to contaminated organic whole milk powder, every whole milk formula brand in the country should have asked one question: where does our milk powder come from?

Nara knew spore-forming bacteria were a risk. It told customers it had screened for clostridia from its very first batch. A company that understood that hazard, and watched its nearest competitor’s outbreak trace back to milk powder, should have checked whether its own formula used the same milk or the same dryer.

If Nara asked, it either learned it shared ByHeart’s supply chain and kept selling, or it got an answer it did not verify. If it never asked, that is its own failure. Either way, Nara kept importing formula made with that milk until April 2026 — five months after the ByHeart recall — and four more babies got sick.

What we still don’t know

• Where the spores got in. FDA says there is not yet enough evidence to tell whether the milk was contaminated before drying or during it.
• Which DFA plant dried Nara’s milk. ByHeart’s powder was dried at DFA’s Fallon, Nevada plant. FDA’s Nara findings name DFA but not the plant.
• Who sold the powder to Germany. Organic West resold the dried powder to ByHeart. Whether it, DFA or a broker sold the powder to Elb-Milch has not been made public.
• Who chose U.S. milk. Nara marketed EU standards. Whether Nara or Elb-Milch decided to use U.S. organic whole milk powder is unknown.
• What anyone tested. Did Elb-Milch or Nara test incoming powder for C. botulinum spores after the ByHeart recall became public?

Why it matters

Parents who paid a premium for Nara bought a promise of European safety standards. What they got was formula built on the same California milk powder that had already sickened babies through ByHeart. A “Made in Germany” label told them where the formula was mixed, not where its main ingredient came from.

This outbreak also shows how little the system knows about who supplies whom. FDA asked the right question in 2025 and, by its own account, got an incomplete answer. Infant formula supply chains should not depend on a supplier’s voluntary customer list. Ingredient sourcing should be traceable, and whole milk powder destined for infant formula should be tested for C. botulinum spores.

That is why I am filing a citizen petition with FDA, joined by 46 parents of 24 infants sickened in the ByHeart and Nara outbreaks. It asks FDA to add C. botulinum and the other botulinum toxin-producing clostridia to the required tests for powdered infant formula, to require that every lot of whole milk powder and other dairy ingredients test negative before it is used, and to require formula makers to keep records tracing each ingredient lot back to its dryer and its dairy farms. Had those records been required, the shared supply chain would have been sitting in Nara’s files when ByHeart sent its families there.

References

• FDA, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026)
• FDA, Nara Organics recall announcement (June 13, 2026)
• AAP News, Second infant botulism outbreak linked to baby formula is over
• Food Safety News, Companies that produced organic powdered milk for ByHeart named
• PBS NewsHour / AP, Two companies supplied dried milk powder linked to botulism in ByHeart formula
• Food Safety News, German company made the infant formula linked to botulism outbreak
• eFoodAlert, Nara Organics: Manufactured in Germany; Packaged in Denmark
• eFoodAlert, Nara’s German manufacturer fails FDA inspection
• Healthbeat, Second baby formula recall linked to botulism raises questions about safety, oversight
• FDA, Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
• AP / CBS News, ByHeart infant botulism outbreak ends with 48 babies sickened
• Food Safety Magazine, ByHeart outbreak ends with extensive WGS evidence
• Marler Blog, ByHeart Is “Discontinued”

WHAT IS INFANT BOTULISM AND CLOSTRIDIUM BOTULINUM?

Clostridium botulinum is an obligate anaerobic, spore-forming, Gram-positive bacillus whose primary, native habitat is the soil.^[1] It thrives in low-oxygen environments and produces botulinum neurotoxin, one of the most lethal biological substances known. The spores themselves are widespread in the environment and harmless to most older children and adults, but the toxin the bacteria produce attacks the nervous system and causes botulism, a severe paralytic illness.

Types of Botulism:

• Foodborne: Caused by eating foods contaminated with the toxin, often from improper home-canning or poorly preserved foods.
• Infant: Occurs when babies (under one year old) ingest the bacterial spores, which then germinate and produce toxins in the gut. This is why honey should never be given to a child under one year old. Contaminated powdered infant formula has now been identified as a second avoidable vehicle.
• Wound: Happens when C. botulinum spores infect a cut or wound and produce toxins, commonly associated with the use of contaminated injection drugs.
• Iatrogenic Botulism: A rare type that occurs if too much botulinum toxin is injected for cosmetic purposes (like wrinkle reduction) or medical conditions (like migraines).
• Adult Intestinal Toxemia: An extremely rare condition in older children and adults where spores colonize the intestinal tract and produce toxin (like infant botulism).

A.  Where Does Clostridium Botulinum Come From?

1.  Soil and Sediment: The Ultimate Natural Reservoir

Landmark environmental surveys dating back over a century have established that viable C. botulinum spores reside in ground soils, dust, and aquatic sediments across every continent where they have been sought. The distribution of specific toxin types in infant botulism cases typically reflects the geographic prevalence of those strains in the local soil. For example, in the United States, Type A spores are predominantly found in the western states, while Type B spores are more densely concentrated in the eastern and mid-Atlantic states. Because spores are highly resistant to environmental stressors (such as drying, heat, and UV light), they easily become airborne. Dust inhalation or ingestion is now considered a primary and largely unavoidable exposure route.^[2] Epidemiological studies have associated infant botulism cases with residence in windy or dusty locations, as well as proximity to dust-generating activities.

2.  Honey: The Longest-Recognized Identifiable and Avoidable Food Source

While environmental exposure is largely unpreventable, honey has long been recognized as the most significant avoidable foodborne vehicle for C. botulinum spores.^[3] C. botulinum is not a disease of the honeybee. Instead, honey becomes an accidental repository when bees carry environmental dust, water, or pollen contaminated with spores back to the hive.^[4] Because honey is typically consumed raw (unpasteurized and non-irradiated), and because bacterial spores are uniquely structurally adapted to survive low-moisture environments, the dormant spores remain viable inside the honey matrix indefinitely. Globally, about 4% of retail honey specimens test positive for Clostridium botulinum spores, though regional rates vary widely. While some localized surveys find no spores, others report contamination rates as high as 10% to 20% depending on the source and processing methods.^[5]

3.  Powdered Infant Formula: A Newly Documented Vehicle

Until recently, honey was the only food widely recognized as a source of C. botulinum spores in infants. That changed in 2025. Beginning in November of that year, FDA and CDC investigated a multistate outbreak of infant botulism among infants fed ByHeart Whole Nutrition powdered infant formula; the outbreak closed with 28 confirmed and 20 probable cases, and C. botulinum was detected in an open can of the formula, in unopened cans from a lot fed to a patient, and in the base mix used to make the product. In June 2026, a second outbreak was linked to Nara Organics powdered infant formula, with four confirmed cases in California, Pennsylvania, and Washington. Both brands’ formulas were made with milk from the same supplier, spray dried by the same processor. Powdered infant formula is not a sterile product, and the heat used in its manufacture does not reliably destroy bacterial spores. Because detection of C. botulinumin powder is scientifically difficult, FDA has cautioned that a negative test does not rule out the presence of the organism in a product.^[6]

B.  Infant Botulism and Clostridium botulinum

Infant botulism is a rare but serious paralytic illness of babies, usually affecting infants younger than one year. It is caused when an infant swallows spores of Clostridium botulinum, or rarely related toxin-producing Clostridium species, and those spores survive, germinate, and multiply in the immature intestine. The bacteria then produce botulinum neurotoxin inside the infant’s gut. In plain terms, the baby does not simply ingest a “germ”; the infant’s bowel becomes the place where the toxin is made.^[7] [8]

That mechanism is what separates infant botulism from classic foodborne botulism. In foodborne botulism, a child or adult typically swallows toxin that has already formed in contaminated food. In infant botulism, the infant swallows spores, and the toxin is produced after the spores colonize the intestine. Infants are uniquely vulnerable because their gut microbiome, bile-acid profile, immune defenses, and intestinal motility are still developing, and they do not yet have the mature protective intestinal flora that usually prevent C. botulinum spores from gaining a foothold in older children and adults.^[9] [10] Infant botulism is the most commonly reported form of botulism in the United States, accounting for roughly 70% of all reported botulism cases, or about 100 to 150 cases in a typical year. Approximately 90% to 95% of cases occur in infants under six months of age, with a median age at onset of about four months. Most cases are caused by toxin type A or type B.^[11] Because such spores are so widespread in the environment, in many individual cases the exact source is never identified.^[12]

C.  Signs and Symptoms in Infants

Infant botulism often begins subtly and then progresses over hours to days. Constipation is commonly one of the earliest signs, followed by poor feeding, weak suck, weak or altered cry, drooping eyelids, diminished facial expression, reduced gag reflex, poor head control, generalized hypotonia, lethargy, and respiratory difficulty. CDC’s clinical overview specifically lists constipation, poor feeding, ptosis, sluggish pupils, flattened facial expression, diminished suck and gag reflexes, weak or altered cry, and respiratory difficulty or arrest as typical findings.^[13] Common signs include:

• Constipation, often for several days;
• Poor feeding, with weak sucking and swallowing;
• A weak, altered, or soft cry;
• Drooping eyelids (ptosis), sluggish pupils, and reduced eye movement;
• Generalized weakness and low muscle tone—the classic “floppy baby”;
• Lethargy and a diminished gag reflex; and
• Breathing difficulty, progressing in severe cases to respiratory failure—the most dangerous complication.

Because these early signs mimic more common conditions, a high index of suspicion matters. A baby with poor feeding, a weak cry, and increasing floppiness—especially with any breathing difficulty—needs urgent evaluation.^[14]

D.  Botulism in Older Children and Adults

The same toxin can cause serious illness in older children and adults, but the exposure pattern is different. Foodborne botulism occurs when a person eats food in which toxin has already formed, classically improperly canned, preserved, fermented, or stored low-acid foods. Wound botulism occurs when spores contaminate a wound and produce toxin in devitalized tissue; in modern U.S. practice, this is often associated with injection-drug use. Iatrogenic botulism can occur after excessive or improperly administered therapeutic or cosmetic botulinum toxin. Adult intestinal colonization botulism is rare but can occur when the adult gut is altered by surgery, antibiotics, bowel disease, or other disruptions.^[15] [16]

In non-infant botulism, symptoms often begin with cranial nerve findings such as blurred or double vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and facial weakness. Weakness then typically descends symmetrically from the face and neck to the arms, trunk, and legs. Patients are usually awake and afebrile, and sensation is usually preserved, which can make the paralysis especially frightening. Severe cases require intubation and mechanical ventilation. Id.

E.  Diagnosis and Laboratory Detection

Botulism is first and foremost a clinical diagnosis. Laboratory confirmation is important, but treatment should not wait for test results when the clinical picture is concerning. CDC’s 2021 clinical guidelines emphasize that timely diagnosis is crucial because antitoxin is the only specific therapy and should be administered as quickly as possible. Because the antitoxin works best when given early, clinicians treat as soon as infant botulism is reasonably suspected.^[17]

For infants, definitive testing usually requires stool or enema specimens, which can be tested for botulinum toxin and cultured for C. botulinum. Testing is specialized and is generally coordinated through state public health laboratories, CDC, and the California Department of Public Health Infant Botulism Treatment and Prevention Program. CDC advises that this specialized testing often takes days and that clinicians should not delay BabyBIG treatment while awaiting confirmation.^[18]

In outbreak investigations, public health laboratories may also test leftover foods, unopened products, ingredients, environmental samples, and bacterial isolates from patients. Whole-genome sequencing can compare isolates from patients, products, and ingredients to determine whether they are genetically related. In the 2025 ByHeart outbreak, that genetic comparison was central because isolates from clinical samples, finished formula, and the base mix used to make it clustered together. In the 2026 Nara Organics outbreak, sequencing tied a clinical isolate from an infant fed one brand of formula to a clinical isolate, a base powder sample, and four samples of unopened cans of a different brand. FDA concluded that the matching sequences, together with the supply-chain commonalities, indicated a common source of contamination between the two outbreaks, while stating that it still could not say whether the milk was contaminated before or during spray drying. There is yet no standardized method for detecting C. botulinum or its spores in powdered formula, and only a limited number of laboratories perform the testing. The FDA’s outbreak workflow enriches a 200-gram sample for up to five days, screens the enrichment by quantitative PCR, and confirms positives by mass spectrometry for active toxin and by whole genome sequencing; the FDA describes that workflow as interim, pending method validation and approval.^[19] [20]

F.  Treatment

Infant botulism is highly treatable, and the great majority of babies recover fully. Care rests on two pillars: specific antitoxin and supportive care.^[21] Treatment has two parts: neutralizing circulating toxin and supporting the patient while nerves recover. For infants, the specific treatment is human botulism immune globulin intravenous, known as BIG-IV or BabyBIG. BabyBIG is FDA-approved for infant botulism types A and B and is obtained in the United States through the Infant Botulism Treatment and Prevention Program. The treating physician contacts the program for immediate consultation; if the presentation supports infant botulism, BabyBIG is released and treatment begins without waiting for final laboratory confirmation.^[22] [23]

The evidence for BabyBIG is strong. In a randomized, double-blind, placebo-controlled California trial of 122 infants with laboratory-confirmed infant botulism, reported in the New England Journal of Medicine in 2006, treatment within three days of hospital admission reduced mean hospital stay from 5.7 weeks to 2.6 weeks. It also reduced ICU time, mechanical ventilation time, tube or intravenous feeding time, and hospital charges. In plain language, BabyBIG does not instantly make the baby well, but it stops additional circulating toxin from binding and can substantially shorten the illness.^[24]

Supportive care is equally important. Infants may need close ICU monitoring, respiratory support, mechanical ventilation, suctioning, prevention of aspiration, nutritional support through nasogastric or other tube feeding, bowel care, occupational therapy, feeding therapy, physical therapy, and careful discharge planning. Antibiotics are generally not used to treat infant botulism itself because bacterial killing in the gut may increase toxin release; aminoglycosides and certain other medications that impair neuromuscular transmission are avoided because they can worsen weakness.^[25]

For older children and adults with suspected foodborne, wound, or other non-infant botulism, the specific antitoxin is generally heptavalent botulinum antitoxin, obtained through public health authorities and CDC. As with infants, antitoxin should be given as early as possible, because it neutralizes toxin that has not yet bound to nerves. Wound botulism also requires wound evaluation and debridement, and antibiotics may be used for wound infection after antitoxin decisions are addressed.^[26] [27]

G.  Prognosis, Recovery, and Complications

With prompt recognition, BabyBIG, and modern intensive care, most infants survive and recover. That favorable long-term prognosis, however, should not obscure the severity of the acute illness, which is frightening, often protracted, and frequently requires weeks of intensive hospital care. The recognized complications include:

• Respiratory failure, apnea, and aspiration—the principal reason a ventilator may be required (on average roughly three weeks when needed);
• Prolonged feeding difficulty—safe oral feeding can take many weeks to return;
• Autonomic effects such as urinary retention, and secondary infections (e.g., pneumonia, ear infection) acquired in the hospital;
• Prolonged general weakness during recovery.^{[28] [29] [30]}

A baby with infant botulism may spend days to weeks unable to feed safely, protect the airway, or breathe without support. Families may experience a prolonged hospitalization, transfer to a tertiary children’s hospital, repeated testing, feeding-tube dependence, ventilator care, and months of follow-up.^[31] In the 2025 ByHeart-formula outbreak, CDC EIS preliminary data found that approximately two-thirds of evaluated infants required post-hospitalization physical therapy or feeding support.^[32] Reasonable follow-up commonly includes primary care, neurology as needed, feeding or speech therapy, physical and occupational therapy, nutrition monitoring, developmental surveillance, and assessment for residual weakness, dysphagia, oral aversion, motor delay, or caregiver trauma. Id. Lasting neurological after-effects are seldom seen, and most infants regain normal strength and development; severe long-term harm is rare. Follow-up with neurology and physiotherapy is advisable after a severe episode.^[33]

THE 2026 NARA ORGANICS INFANT FORMULA BOTULISM OUTBREAK

A.  Extraordinary Circumstances

Infant botulism is normally sporadic; bacterial spores are widely present in soil and dust around the country and therefore may cause sporadic, random infections. A multistate outbreak of infant botulism tied to a manufactured product is therefore unusual,^[34] and until 2025, it had never happened. According to the FDA, the 2025 ByHeart outbreak was the first botulism outbreak tied to infant formula in the United States since the infection was first described about fifty years ago.^[35] The Nara Organics outbreak of 2026 is the second, and it followed the first by seven months. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) concluded that epidemiologic, traceback and laboratory evidence showed that Nara Organics Whole Milk Organic Infant Formula was contaminated with C. botulinum and made infants sick, and that the data indicate a common source of contamination in the Nara Organics outbreak and the 2025 ByHeart outbreak.^[36]

B.  What Makes Formula Vulnerable

Powdered infant formula is not sterile, and the pathogens usually tested for (such as Cronobacter and Salmonella) do not form spores and are killed by pasteurization. Spore-forming bacteria, like C. botulinum, are different: their heat-resistant spores can survive normal processing. The 2025 ByHeart botulism outbreak prompted the FDA and international food-standards bodies to begin a formal risk assessment of spore-forming organisms in powdered infant formula. At the Reagan-Udall Foundation’s July 2026 roundtable, a Cornell University dairy microbiologist described spores as ubiquitous in soil, manure, bedding and silage, tracing the routes by which they move from those sources to the cow’s teat and into bulk tank milk, noted that weather may be significant to spore transmission on organic dairy farms when cows are on pasture, and cautioned that processing technologies such as bacterial centrifugation and microfiltration can meaningfully reduce spore loads but are not a complete solution.^[37]

Related findings in soft, high-moisture dairy products, such as Italian mascarpone cheese, and in raw milk associated with bovine botulism confirm that C. botulinum can and does contaminate the dairy matrix when conditions allow.^[38] It is becoming apparent that dried milk product, such as infant formula, is equally vulnerable to contamination. The studies significant to the link between botulism and infant formula, beyond the current outbreaks, are summarized below:

Source	What was tested	Key finding
Nadala et al., Front. Microbiol., 2026 (USA)	Unopened formula containers and bulk “base powder” (formula before packaging)	C. botulinum found in both finished product and base powder, even where the usual indicator organism was non-detectable, so standard screening would have missed it.
Brett et al., J. Med. Microbiol., 2005 (UK, 2001 case)	14 home foods from a 5-month-old with infant botulism	Type B C. botulinum recovered from an opened can of infant formula milk powder; two product isolates matched the infant’s isolate by the molecular typing methods then available.
Luo et al., Chinese J. Food Hygiene, 2023 (China)	30 batches of infant formula milk powder from a company tied to a botulism case	While its toxin was not detected directly, C. botulinum (type B) was isolated from one batch of milk powder.
Barash et al., J. Pediatr., 2010 (USA)	30 patient-used formula samples and nine market-bought formulas	Clostridium spores in 17% of patient-used and 78% of market formulas — but none were C. botulinum (they were related Clostridium species).

Full citations for the studies above appear at notes 41, 43 and 44, infra.^[39]

The literature also establishes both the historical rarity of C. botulinum in commercial dried milk and formula, and the singular significance of the 2025 and 2026 outbreaks:

• Until 2025, C. botulinum was essentially never found in commercial dried milk or formula. Dedicated surveys, including nonfat dry milk, evaporated milk, and canned formula, historically tested negative.^[40]
• Fluid and raw milk have been found to sometimes carry the organism and toxin due to bovine botulism, and these spores also survive pasteurization, although pasteurization strongly degrades pre-formed toxin.^[41]
• Earlier formula links were single cases with caveats. A 2001 United Kingdom case and a 2023 Chinese investigation each recovered the organism from formula milk powder, but causation was never firmly proven.^[42]
• The 2025 ByHeart outbreak is the turning point and the strongest evidence of milk-powder risk to date. Whole-genome sequencing tied type A C. botulinum in organic whole milk powder to the strain in finished formula and to the strain in sick infants across multiple states.^[43]
• The 2026 Nara Organics outbreak extended the above link to a second brand: an infant who had never consumed ByHeart formula carried a strain indistinguishable from the one in ByHeart’s sealed cans and base powder, with the shared milk powder as the only common element.^[44]

In short, across decades of research, C. botulinum in commercial dried milk or formula was always possible but rarely detected until 2025. That rarity of detection is precisely what makes the clear and complete genetic evidence in these recent outbreaks so revealing of the products’ defective and adulterated condition.

C.  The Outbreak Summary

On Friday, June 12, 2026, the FDA and CDC contacted Nara Organics with information about three infants in California, Washington, and Pennsylvania who had been hospitalized with infant botulism after consuming Nara formula. Nara initiated a recall of every lot on the market that day and announced it the next. A fourth case was added in July, and on August 27, 2026, the CDC declared the outbreak over.

Outbreak Summary Facts
Feature	Summary
Product	Nara Organics Whole Milk Organic Powdered Infant Formula, 700g (UPC 860013251901) and 400g (UPC 860013251918); manufactured in Germany; sold nationally through Target retail stores, Target.com and Nara.com from July 2025 to June 2026; not distributed outside the United States
Case Count (final)	4 infants, all confirmed; no cases added after the July 6, 2026, update
States	California (2), Pennsylvania (1), Washington (1)
Outcomes	All 4 infants hospitalized and treated with BabyBIG; no deaths reported
Illness Onset	April 20, May 17, May 20 and May 31, 2026
Investigation Status	CDC declared the outbreak over on August 27, 2026; FDA’s root cause investigation remains open
Toxin Type	Type A
Laboratory Evidence	C. botulinum detected in an open can of Nara formula fed to one of the ill infants; whole genome sequencing of the Washington infant’s (I.N.’s) clinical isolate was closely related (5 SNPs) to a clinical isolate from the 2025 ByHeart outbreak, a ByHeart base powder sample, and four samples of unopened cans of ByHeart formula
Source	The Nara lots linked to illness were made with organic whole milk supplied by Organic West Milk and spray dried by Dairy Farmers of America — the same suppliers implicated in the 2025 ByHeart outbreak; FDA concluded the sequencing match and the shared supply chain indicate a common source of contamination between the two outbreaks; FDA has not determined whether the milk was contaminated before or during drying, and its incident summary states that the evidence was not sufficient to confirm the sources and routes of contamination
Recall	Initiated June 12 and announced June 13, 2026: all sixteen Nara Organics infant formula lots on the market, including the three lots the first three infants were fed (709125280E14F2, 709125288E14F2 and 708125174E14F2)

Sources: see note 46.^[45]

D.  The FDA and CDC Investigations

The investigation began with that June 12 call. The three infants the agencies described to Nara had been fed lots 709125280E14F2, 709125288E14F2 and 708125174E14F2. Nara initiated the recall that day, and on June 13 it announced the recall of those and 13 other lots that were on the market at the time while stating that, “[t]o date, Nara infant formula has not tested positive for C. botulinum.”^[46]

In June 2026, the FDA reported three known, confirmed C. botulinum type A cases with onsets in April and May 2026. It also reported that the Nara lots linked to these cases had been made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America, the same suppliers of organic whole milk powder implicated in the ByHeart outbreak. Notably, the customer list Organic West Milk had given the FDA during the ByHeart outbreak investigation did not disclose that Organic West Milk also supplied the manufacturer of Nara Organics formula.^[47] On July 6, 2026, the CDC and FDA reports included a fourth case, from California, and reported that laboratory testing had detected C. botulinum in an open can of Nara Organics formula, fed to one of the outbreak cases.^[48]

On August 27, 2026, the CDC declared the outbreak over and stated that traceback and laboratory data showed that Nara Organics Whole Milk Organic Infant Formula was contaminated and made infants sick. CDC reported that whole genome sequencing had linked a case sample from this outbreak to patient, product, and ingredient samples from the prior 2025 ByHeart outbreak, and that the formulas sold by both Nara Organics and ByHeart were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America,^[49] leading the FDA to conclude that the matching sequencing results, together with the supply chain commonalities, indicate a common source of contamination between the two outbreaks, while also stating that there is not yet enough evidence to determine whether the milk was contaminated before drying or during the drying process. The FDA’s incident summary for the Nara investigation identifies the case whose isolate matched: it was the Washington clinical isolate — I.N.’s. The summary also confirms the ingredient supplier commonalities between the two investigations, records that a firm whose name the FDA redacted was placed on Import Alert 40-05 on June 25, 2026, and states that the evidence was not sufficient to confirm the sources and routes of contamination.^[50]

The FDA’s incident record follows liquid whole milk from twenty dairies that was delivered to Dairy Farmers of America’s plant in Fallon, Nevada, where it was spray dried into organic whole milk powder; then Organic West Milk, acting as broker, sold that powder to formula manufacturers and delivered it to them by a third-party carrier.^[51] Nara’s own account of its supply chain confirms that, from October 2024 to April 2025, Nara purchased whole milk from Organic West Milk, which was turned into milk powder at Dairy Farmers of America in Nevada, and that powder went into the formula Nara manufactured in Germany and sold in the United States at the time of the outbreak.

The ByHeart outbreak investigation had already established that the powder from the same supply chain carried viable C. botulinum. At least seventeen product samples tested positive in the ByHeart outbreak investigation — five of them were the organic whole milk powder. Whole genome sequencing sorted the outbreak isolates into seventeen strains, and two of those strains directly linked the Dairy Farmers of America milk to ByHeart’s milk powder and finished product, which was also linked to an unopened can from an Arizona case’s home and to a New Jersey infant case. 

The recovery of the outbreak organism from unopened formula cans denies any suggestion that the strain that infected the outbreak cases was introduced in a home, in retail, or after a seal was broken; it was present in formula made from contaminated milk before the formula left the manufacturer.^[52] Similarly, the identification of a second wave of infant botulism cases following ByHeart’s recall and closeout of its own outbreak suggests that the original source was not yet fully identified and dealt with. Likewise, two infants with botulism who were fed different brands of formula, manufactured by different companies on different continents, were linked to outbreaks seven months apart; the only link between the two cases was the dairy ingredient their formulas shared, which points to the original source of contamination. All these details clearly indicate that milk and/or milk powder were the original source of contamination in both recent infant botulism outbreaks. 

The FDA completed its onsite inspections of ByHeart’s facilities without identifying any facility deficiency that could explain the root cause and has said that its root cause investigation is focused on incoming ingredients and the dairy supply chain. In its presentation to the Reagan-Udall Foundation roundtable in July 2026, ByHeart reported that all 472 environmental tests at its Iowa and Oregon facilities were negative for C. botulinum and that the only ingredient confirmed positive by culture was whole milk powder — they stated that their own internal investigation with their outside laboratory and consultants, and the FDA, had identified the common source of C. botulinum as the whole milk powder. ByHeart has since delisted the supplier.^[53]

The ByHeart outbreak records also show why Nara Organics was not identified at the time. On January 28 and February 3, 2026, FDA’s CORE team issued traceability assignments to six firms that had received lots of Organic West Milk powdered milk that tested positive for C. botulinum, asking for all distribution of that powder to infant formula manufacturers over the prior two years. The result: “None of the firms identified any infant formula manufacturers as customers that were supplied whole milk powder.” Separately, the customer list Organic West Milk itself had given the FDA during the ByHeart investigation omitted Nara Organics.^[54]

In late January 2026, the Associated Press reported that Organic West Milk and Dairy Farmers of America’s Fallon, Nevada plant were the source of the botulism-positive milk powder in the ByHeart outbreak and quoted Dairy Farmers of America’s statement that the powder had met all required tests.^[55] Nara Organics learned from those media reports “in early 2026” that Organic West Milk and Dairy Farmers of America supplied ByHeart. The company then conducted a “rigorous review” of its existing formula containing Organic West Milk, confirmed that its whole milk powder lots did not match those in the implicated ByHeart formula, reviewed its sulfite-reducing clostridia results, and consequently “determined that Nara formula could stay on the market.” As late as June 23, 2026, ten days after their recall, Nara was still stating that “to date, there have been no positive tests or evidence of C. botulinum in Nara’s formula supply chain.”^[56] The four infants linked to the Nara outbreak became ill in April and May 2026, while formula made with that milk remained on sale.

E.  Issues with Nara’s Response

Nara has stated in its June 13, 2026, recall notice, its June 23, 2026, supply chain page, and its August 27, 2026, update that it intends to return the product to market with European dairy and “rigorous C. botulinum testing protocols.” That recall notice also stated that Nara formula “has not tested positive for C. botulinum.” Three weeks later the CDC reported that it had: on July 6, 2026, the agencies announced that the organism had been recovered from an open can of Nara formula fed to one of the ill infants.^[57]

Its August 27 update says that the FDA’s finding “may be linked to one of our former dairy suppliers.” The FDA, by contrast, states the finding directly: that the matching sequencing results and the supply chain commonalities indicate a common source of contamination between the two infant formula outbreaks. Nara’s update then devotes most of its length to what the sequencing could not do — that the infant’s strain did not match the open can from the family’s home, that the other two infants’ strains were unique in the NCBI database and do not match each other, and that the open can is not linked to anything — and closes by stating that FDA’s tests on sealed cans of Nara formula “have returned negative for C. botulinum toxin type A and toxin type B.”^[58] The update, however, concedes that C. botulinum was recovered from a can of Nara formula.

First, the FDA identified seventeen distinct strains from patient, product and ingredient samples in the ByHeart outbreak, and it attributed the breadth of contamination to the distribution and cross-contamination of the ingredients.^[59]As such, an open can that was sampled from an infant’s home weeks after the illness and found to be carrying a different strain than that of the infant is not remarkable, since many strains were associated with the outbreak. Second, a strain that is absent from a public database of environmental C. botulinum sequences indicates that the database is thin, not that the illness is unexplained. What the update passes over in a single sentence is the match that the FDA did find, which links I.N.’s own clinical isolate, at five SNPs, to four sealed cans of ByHeart formula, which were made from the same milk product as the Nara infant formula, and the undeniable association between the ingredients and the cases. 

Third, infant botulism is caused by swallowed spores that germinate and produce toxin inside an infant’s intestine; the toxin is made in the baby, not in the product. The detectable hazard in a can of formula is the spore, and a negative toxin result on a sealed can does not show that the lot was free of spores. That said, there is no standardized method for finding those spores; the FDA’s own outbreak workflow is pending validation; and the Reagan-Udall Foundation’s report on its July 2026 roundtable states that, on the data presented, this contamination should be considered non-homogeneous and to occur at very low levels, which makes detection significantly more difficult. The FDA itself has cautioned that a negative test does not rule out the organism in a product.^[60]

The testing Nara relies on is the testing that failed. Nara screens each batch for sulfite-reducing clostridia as a proxy for C. botulinum and reports every result at or below the limit of detection. The 2026 JEMRA expert group concluded that hygiene indicators do not replace or reduce the need for pathogen-specific testing; the peer-reviewed analysis of the ByHeart product found C. botulinum in finished formula and base powder where the usual indicator organism was non-detectable. ByHeart’s own data, presented at the Reagan-Udall Foundation roundtable, make the point directly: every sample in which its laboratory presumptively detected C. botulinum by PCR—17 in finished product, 3 in base powder and 13 in ingredients—had sulfite-reducing clostridia below 10 CFU/g by direct plating, the same below-detection result Nara reports for its batches. ByHeart’s conclusion was that the results show the limited reliability of direct-plating SRC as an indicator, and the Foundation’s report states that trace amounts of spores can be present at levels too low for SRC detection by direct plating and yet enough to make infants sick.^[61] Dairy Farmers of America likewise told the Associated Press that its powder met all required tests. Both Nara and Dairy Farmers of America have treated the existing test as a badge of security when the outbreaks and research reveal that the test is in fact faulty.

F.  FDA’s Response

On July 13, 2026, the FDA shared a letter for the infant formula industry — addressed to manufacturers, packagers, distributors, exporters, importers, and retailers involved in the manufacture or distribution of infant formula and infant formula ingredients — signed by Donald A. Prater, DVM, Acting Deputy Commissioner for Food. The letter was a response to the two multistate outbreaks of infant botulism linked to powdered infant formula and a separate cereulide intoxication event traced to a contaminated formula ingredient. The letter declared that a manufacturer’s responsibility for safety and quality extends to every ingredient, every supplier, and every link in the supply chain.^[62]

The letter confirms facts central to this claim. It states that FDA collected samples at Dairy Farmers of America, the processor for Organic West Milk; that two samples from one lot of organic whole milk powder matched a clinical sample and an infant formula sample by whole genome sequencing; that its ongoing root-cause investigation is focused on ingredients and their production environments; and that Organic West Milk also supplied Nara Organics, which recalled all lots of its formula after the June 2026 outbreak.^[63]

Reiterating its March 2023 letter to the industry, the agency states that suppliers of ingredients that do not receive treatment at the formula plant are still an extension of the manufacturing process. Under 21 C.F.R. Part 106, manufacturers must maintain production and in-process controls from the receipt of raw materials through distribution, including ingredient specifications, quarantine and disposition of nonconforming ingredients, and scheduled audits. Under 21 C.F.R. Part 117, manufacturers and their supply chain partners must implement a food safety plan with a hazard analysis, preventive controls, and a risk-based supply chain program that identifies hazards in ingredients, approves suppliers and verifies them, including by onsite audits.^[64]

Most significant for this claim, the FDA directs manufacturers to stay abreast of recall notifications and outbreak investigations, which “may serve as safety signals” that an ingredient or supplier is substandard, and warns that ignoring or downplaying such signals can lead to public health events that could have been avoided. The agency expects manufacturers to act swiftly to assess and address the risk when a contaminated ingredient or supplier concern is identified whether by the FDA or through the manufacturer’s own monitoring.^[65] Nara had exactly such a signal. Its milk supplier and spray dryer were publicly identified as the source of botulism-positive milk powder in January 2026. By its own account Nara reviewed the signal, relied on the same indicator testing that had failed to detect the hazard in ByHeart’s product, and left the formula on the market. The four Nara-associated infants became ill over the following four months.

The scientific response has reached the same conclusions. The joint FAO/WHO expert meeting convened in Rome in June 2026 formally added botulinum neurotoxin-producing Clostridia to the priority list of hazards for powdered formula, concluding that dairy ingredients have been demonstrated as a vehicle for such spores; recommended that manufacturers implement supplier risk management programs to address such spores, stating that control starts with on-farm practices; and concluded that hygiene indicators do not replace or reduce the need for pathogen-specific testing. Each of these findings is an acknowledgment that the controls in place when these infants were exposed to finished formula were not adequate.^[66]

On September 3, 2026, the Reagan-Udall Foundation for the FDA published its report on a July 13, 2026, roundtable on C. botulinum in powdered infant formula, a meeting convened in collaboration with ByHeart and the International Dairy Foods Association. Even this industry-funded forum arrived at compatible findings. The report states that, before November 2025, C. botulinum had not been demonstrated to cause outbreaks of infant botulism through infant formula, and that the recent outbreaks demonstrated that they can. It states that the industry cannot rely on testing alone to ensure the safety of products for the most vulnerable populations; that direct-plating SRC testing can miss spores present at levels sufficient to make infants sick; that there are no standardized methods for detecting the organism or its spores in infant formula; and that data on the prevalence of C. botulinum on farms and in the supply chain are limited. Its first recommendation is an assessment of that prevalence on farms, along the supply chain and in finished goods, and its seventeenth asks the FDA to provide guidance on fit-for-purpose tests and thresholds and to establish standardized testing methods and requirements.^[67]

The FDA’s post-outbreak work has continued since the close-out. In the September 22, 2026, update of its post-outbreak response page, the agency reported that its root cause investigation continues, with its assessment directed at the supply chain and dairy-based ingredients; that a February 2026 surveillance sampling of 48 powdered milk samples from four suppliers to infant formula manufacturers found two samples, both organic nonfat milk powder from a single firm, positive by PCR, with whole genome sequencing confirming Clostridium sporogenes carrying a gene highly associated with botulinum toxin B1; that it has engaged Cornell University’s Pathogenic Spore Consortium on strategies to reduce C. botulinum and other spore-formers in milk; and that it has asked the International Commission on Microbiological Specifications for Foods — the body whose recommendation Nara cites for its sulfite-reducing clostridia screen — to revisit its publication on the usefulness of testing for C. botulinum in powdered infant formula and dairy-based ingredients for infant formula, in light of the recent outbreaks.^[68]

---

^[1] Jin, J. (2023). What is botulism? Journal of the American Medical Association (JAMA), 330(1), 90. https://jamanetwork.com/journals/jama/issue/330/1

^[2] Dabritz, H. A., Chung, C. H., Read, J. S., & Khouri, J. M. (2025). Global occurrence of infant botulism: 2007–2021. Pediatrics, 155(4), e2024068791.

^[3] Harris, R. A., & Dabritz, H. A. (2024). Infant botulism: in search of Clostridium botulinum spores. Current Microbiology, 81(10), 306. https://link.springer.com/article/10.1007/s00284-024-03828-0

^[4] Schneider, K. R., Schneider, R. M. G., Kurdmongkoltham, P., & Bertoldi, B. (2025). Preventing foodborne illness: Clostridium botulinum. https://ask.ifas.ufl.edu/publication/FS104

^[5] Harris, R. A., & Dabritz, H. A. (2024). Infant botulism: in search of Clostridium botulinum spores. Current Microbiology, 81(10), 306. https://link.springer.com/article/10.1007/s00284-024-03828-0

^[6] Centers for Disease Control and Prevention, Infant Botulism Outbreak Linked to Infant Formula, November 2025 (update of Mar. 5, 2026), https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/index.html (the outbreak included 28 confirmed cases and 20 probable cases); U.S. Food and Drug Administration, Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) (content current as of June 3, 2026), https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025 (case counts: 28 confirmed, 20 probable; sample results: opened container of ByHeart formula tested by CDPH and unopened container collected by Arizona, each positive for C. botulinum type A; a sample of base mix matching four isolates from one lot of ByHeart formula reported by a patient; spores are heat-resistant and require special activation before they can be detected; “a negative test result does not rule out the presence of the bacteria in the product”); FDA, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026), supra note 1 (Nara outbreak; milk supplied by Organic West Milk and spray dried by Dairy Farmers of America for both brands); Reagan-Udall Foundation for the FDA, Applying the Science of Infant Formula Safety: Insights from Recent Recall Activity and the Latest Research on C. botulinum (Sept. 2026), https://reaganudall.org/publications/applying-science-infant-formula-safety (report of an invitation-only roundtable held July 13, 2026, convened in collaboration with ByHeart and the International Dairy Foods Association, which provided funding for the project; the report states that listing a contributor does not represent that contributor’s endorsement) [hereinafter Reagan-Udall Report], at 5 (before November 2025, C. botulinum had not been demonstrated to cause outbreaks of infant botulism through its presence in infant formula; the recent U.S. outbreaks demonstrated that pathway), 8–9 (contamination should be considered non-homogeneous and to occur at very low levels; trace amounts of spores can be present at levels too low for detection of sulfite-reducing clostridia by direct plating but enough to make infants sick) & App. B, slide 3, at 22 (CDC investigation summary for the ByHeart outbreak, as presented by ByHeart: 48 cases, 28 confirmed and 20 probable; 48 hospitalizations; no deaths; 17 states; illness onsets Dec. 24, 2023 to Nov. 29, 2025). See also Section II.B, infra.

^[7] CDC. Clinical Overview of Infant Botulism. April 24, 2024. https://www.cdc.gov/botulism/hcp/clinical-overview/infant-botulism.html

^[8] Rao AK, Sobel J, Chatham-Stephens K, Luquez C. (2021). Clinical Guidelines for Diagnosis and Treatment of Botulism. MMWR Recomm Rep. 2021;70(2):1-30. https://www.cdc.gov/mmwr/volumes/70/rr/rr7002a1.htm

^[9] CDC. Clinical Overview of Infant Botulism. April 24, 2024. https://www.cdc.gov/botulism/hcp/clinical-overview/infant-botulism.html

^[10] Rosow LK, Strober JB. Infant Botulism: Review and Clinical Update. Pediatr Neurol. 2015;52(5):487-492. https://doi.org/10.1016/j.pediatrneurol.2015.01.006

^[11] Dabritz et al., supra note 3; CDC, National Botulism Surveillance Summary, 2021, https://www.cdc.gov/botulism/php/national-botulism-surveillance/2021.html.

^[12] Harris & Dabritz, supra note 4; American Family Physician (AAFP), Infant Botulism, https://www.aafp.org/pubs/afp/issues/2002/0401/p1388.html.

^[13] CDC. Clinical Overview of Infant Botulism. April 24, 2024. https://www.cdc.gov/botulism/hcp/clinical-overview/infant-botulism.html

^[14] CDC, Clinical Overview of Infant Botulism, supra note 8; Jin, supra note 2.

^[15] Rao AK, Sobel J, Chatham-Stephens K, Luquez C. (2021). Clinical Guidelines for Diagnosis and Treatment of Botulism. MMWR Recomm Rep. 2021;70(2):1-30. https://www.cdc.gov/mmwr/volumes/70/rr/rr7002a1.htm

^[16] Jeffery IA, Nguyen AD, Karim S. Botulism. [Updated 2024 Nov 25]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459273/

^[17] Rao AK, Sobel J, Chatham-Stephens K, Luquez C. (2021). Clinical Guidelines for Diagnosis and Treatment of Botulism. MMWR Recomm Rep. 2021;70(2):1-30. https://www.cdc.gov/mmwr/volumes/70/rr/rr7002a1.htm

^[18] CDC. Clinical Overview of Infant Botulism. April 24, 2024. https://www.cdc.gov/botulism/hcp/clinical-overview/infant-botulism.html

^[19] CDC. Investigation Update: Infant Botulism Outbreak, November 2025. March 4, 2026. https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/investigation.html

^[20] FDA. Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). Content current as of June 3, 2026. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025; U.S. Food and Drug Administration, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026), update of Aug. 27, 2026, https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026; Centers for Disease Control and Prevention, Infant Botulism Outbreak Linked to Powdered Infant Formula, June 2026, and its investigation, locations and timeline subpages, update of Aug. 27, 2026, https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/index.html; investigation update at https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html; Reagan-Udall Report, supra note 7, at 8 (no standardized methods for detecting the organism or its spores in the infant formula industry; only a limited number of laboratories perform testing) & App. D, at 41 (FDA, Summary C. Botulinum Workflow (outbreak): 200 g sample of powdered infant formula or milk powder, enrichment with incubation of up to five days, qPCR, EndoPep mass spectrometry, whole genome sequencing and mouse bioassay; “Interim Workflow, finalization pending method validation and approval”).

^[21] Jeffery IA, Nguyen AD, Karim S. Botulism. [Updated 2024 Nov 25]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459273/

^[22] CDC. Clinical Overview of Infant Botulism. April 24, 2024. https://www.cdc.gov/botulism/hcp/clinical-overview/infant-botulism.html

^[23] Scarborough, A. P., Khouri, J. M., Chung, C. H., Dabritz, H. A., & Read, J. S. (2025). International Experience with Human Botulism Immune Globulin for the Treatment of Infant Botulism. Medical Research Archives, 13(10). https://esmed.org/MRA/mra/article/view/7026

^[24] Arnon SS, Schechter R, Maslanka SE, Jewell NP, Hatheway CL, Human Botulism Immune Globulin for the Treatment of Infant Botulism, 354 N. Engl. J. Med. 462 (2006) (the randomized, double-blind, placebo-controlled trial of 122 infants described in the text); Scarborough, A. P., Khouri, J. M., Chung, C. H., Dabritz, H. A., & Read, J. S. (2025). International Experience with Human Botulism Immune Globulin for the Treatment of Infant Botulism. Medical Research Archives, 13(10). https://esmed.org/MRA/mra/article/view/7026

^[25] Rao AK, Sobel J, Chatham-Stephens K, Luquez C. (2021). Clinical Guidelines for Diagnosis and Treatment of Botulism. MMWR Recomm Rep. 2021;70(2):1-30. https://www.cdc.gov/mmwr/volumes/70/rr/rr7002a1.htm

^[26] Jeffery IA, Nguyen AD, Karim S. Botulism. [Updated 2024 Nov 25]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459273/

^[27] Scarborough, A. P., Khouri, J. M., Chung, C. H., Dabritz, H. A., & Read, J. S. (2025). International Experience with Human Botulism Immune Globulin for the Treatment of Infant Botulism. Medical Research Archives, 13(10). https://esmed.org/MRA/mra/article/view/7026

^[28] Scarborough, A. P., Khouri, J. M., Chung, C. H., Dabritz, H. A., & Read, J. S. (2025). International Experience with Human Botulism Immune Globulin for the Treatment of Infant Botulism. Medical Research Archives, 13(10). https://esmed.org/MRA/mra/article/view/7026

^[29] Morris, V., Wians, R., Wilson, J., & Stevens, G. (2022). Infant Botulism. Journal of Education & Teaching in Emergency Medicine, 7(2), S48. https://pmc.ncbi.nlm.nih.gov/articles/PMC10332751/

^[30] Rosow & Strober, supra note 11.

^[31] Scarborough, A. P., Khouri, J. M., Chung, C. H., Dabritz, H. A., & Read, J. S. (2025). International Experience with Human Botulism Immune Globulin for the Treatment of Infant Botulism. Medical Research Archives, 13(10). https://esmed.org/MRA/mra/article/view/7026

^[32] CDC EIS Conference. Severity of Illness and Clinical Outcomes of Infants Linked to an Infant Botulism Outbreak Caused by Powdered Infant Formula — United States, 2025. April 17, 2026. https://www.cdc.gov/eis-conference/php/abstracts/infant-botulism-outbreak-caused-by-powdered-infant-formula.html

^[33] AAFP, supra note 13; Rosow & Strober, supra note 11; Botulism Sequelae: A Systematic Review, PMC, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12798721/.

^[34] Harris, R. A., & Dabritz, H. A. (2024). Infant botulism: in search of Clostridium botulinum spores. Current Microbiology, 81(10), 306. https://link.springer.com/article/10.1007/s00284-024-03828-0

^[35] FDA. Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). Content current as of June 3, 2026. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025; Letter from Donald A. Prater, DVM, Acting Deputy Comm’r for Food, U.S. Food & Drug Admin., Human Foods Program, to Infant Formula Industry (July 13, 2026), https://www.fda.gov/media/193534/download, at 1 (ByHeart outbreak was the first botulism outbreak definitively tied to infant formula in the United States since infant botulism was first described as a distinct clinical entity nearly fifty years ago); Reagan-Udall Report, supra note 7, at 5 (prior to November 2025, C. botulinum had not been demonstrated to cause outbreaks of infant botulism due to its presence in infant formula, consistent with guidance from the International Commission on Microbiological Specifications for Foods).

^[36] Centers for Disease Control and Prevention, Infant Botulism Outbreak Linked to Powdered Infant Formula, June 2026, and its investigation, locations and timeline subpages, update of Aug. 27, 2026, https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/index.html; investigation update at https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html (epidemiologic, traceback, and laboratory data showed that Nara Organics Whole Milk Organic Infant Formula was contaminated and made infants sick; data indicate a common source of contamination for this outbreak and the 2025 ByHeart outbreak).

^[37] U.S. FDA, FDA’s Actions to Respond to Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula, https://www.fda.gov/food/outbreaks-foodborne-illness/fdas-actions-respond-clostridium-botulinum-illnesses-associated-consumption-powdered-infant-formula; Contemporary Pediatrics, Infant botulism outbreak linked to powdered formula under FDA investigation, https://www.contemporarypediatrics.com/view/infant-botulism-outbreak-linked-to-powdered-formula-under-fda-investigation; Reagan-Udall Report, supra note 7, App. C, slides 1–19, at 31–40 (Nicole Martin, PhD, Cornell University, Bacterial spore prevalence in the dairy system and mitigation strategies).

^[38] Franciosa G, et al., Clostridium botulinum spores and toxin in mascarpone cheese and other milk products, 62 J. Food Prot. 867 (1999), https://pubmed.ncbi.nlm.nih.gov/10456738/; Aureli P, et al., an outbreak in Italy of botulism associated with a dessert made with mascarpone cream cheese, 16 Eur. J. Epidemiol. 913 (2000), https://pubmed.ncbi.nlm.nih.gov/11338122/.

^[39] Nadala et al., infra note 44 (C. botulinum present in finished product and bulk “base powder,” with genetic identity between a finished lot and a base powder, and detectable even where the usual indicator organism, sulfite-reducing clostridia, was non-detectable — such that standard screening would have missed it); Brett, Johnson and Luo, infra note 43; Barash, infra note 41.

^[40] Guilfoyle DE, Yager JF, Survey of infant foods for Clostridium botulinum spores, 66 J. Assoc. Off. Anal. Chem. 1302 (1983), https://pubmed.ncbi.nlm.nih.gov/6355058/; Barash JR, et al., Clostridial spores in powdered infant formula, J. Pediatr. (2010), https://www.jpeds.com/article/S0022-3476(10)00070-3/fulltext.

^[41] Böhnel H, et al., Presence of Clostridium botulinum and botulinum toxin in milk and udder tissue of dairy cows with suspected botulism, Vet. Rec. (2013), https://pubmed.ncbi.nlm.nih.gov/23585115/; Lindström M, et al., Clostridium botulinum in cattle and dairy products, 50 Crit. Rev. Food Sci. Nutr. 281 (2010), https://pubmed.ncbi.nlm.nih.gov/20301016/; Weingart OG, et al., The Case of Botulinum Toxin in Milk: Experimental Data, 76 Appl. Environ. Microbiol. 3293 (2010), https://aem.asm.org/content/76/10/3293.full.

^[42] Brett MM, et al., A case of infant botulism with a possible link to infant formula milk powder, J. Med. Microbiol. (2005), https://pubmed.ncbi.nlm.nih.gov/16014431/; Johnson EA, et al., Characterization of Clostridium botulinum Strains Associated with an Infant Botulism Case in the United Kingdom, 43 J. Clin. Microbiol. 2602 (2005), https://pmc.ncbi.nlm.nih.gov/articles/PMC1151885; Luo H, et al., Isolation and typing of Clostridium botulinum from milk powder of an enterprise associated with a case of infant botulism, 35 Chinese J. Food Hygiene 1475 (2023), https://doaj.org/article/30d4cb5e20434fad9a47a75d7afcd132.

^[43] FDA. Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). Content current as of June 3, 2026. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025; Nadala C, et al., Detection and characterization of Clostridium botulinum isolated from powdered infant formula, 17 Front. Microbiol. 1800624 (2026), https://doi.org/10.3389/fmicb.2026.1800624 (authors from IEH Laboratories and Consulting Group, the laboratory that performed ByHeart’s microbiological testing, and from ByHeart); Reagan-Udall Report, supra note 7, App. B, slides 10 & 13, at 26–27 (whole genome sequencing clusters linking whole milk powder, base powder, finished product and clinical isolates across laboratories).

^[44] U.S. Food and Drug Administration, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026), update of Aug. 27, 2026, https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026 (one Nara Organics clinical isolate matched four samples of unopened cans of ByHeart formula and a ByHeart base powder sample).

^[45] U.S. Food and Drug Administration, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026), update of Aug. 27, 2026, https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026; Centers for Disease Control and Prevention, Infant Botulism Outbreak Linked to Powdered Infant Formula, June 2026, and its investigation, locations and timeline subpages, update of Aug. 27, 2026, https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/index.html; investigation update at https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html; CDC, Investigation Update on Infant Botulism Outbreak, June 2026 (update of July 6, 2026) (four confirmed type A cases: California (2), Pennsylvania (1), Washington (1), all hospitalized and treated with BabyBIG; laboratory testing detected Clostridium botulinum in an open can of Nara Organics formula fed to one of the infants; FDA testing an unopened can from the same lot), https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html; Nara Organics, Nara Organics Recalls All Lots of Nara Infant Formula Because of Possible Health Risk(company announcement posted by FDA, June 13, 2026), https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nara-organics-recalls-all-lots-nara-infant-formula-because-possible-health-risk; Nara Organics, Nara’s Whole Milk Supply Chain (June 23, 2026), https://nara.com/pages/nara-organics-whole-milk-supplier (formula manufactured in Germany; Organic West Milk purchased October 2024 to April 2025 and spray dried at Dairy Farmers of America in Nevada); Reagan-Udall Report, supra note 7, App. B, slide 3, at 22 (CDC investigation summary for the ByHeart outbreak, as presented by ByHeart: 48 cases and 48 hospitalizations; no deaths; 17 states).

^[46] Nara Organics, Nara Organics Recalls All Lots of Nara Infant Formula Because of Possible Health Risk (company announcement posted by FDA, June 13, 2026), https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nara-organics-recalls-all-lots-nara-infant-formula-because-possible-health-risk (FDA and CDC contacted Nara Organics late Friday, June 12, 2026 with three cases; the three infants were hospitalized and treated with BabyBIG in California, Washington, and Pennsylvania; exposure lots 709125280E14F2, 709125288E14F2 and 708125174E14F2; sixteen lot codes recalled; distribution through Target retail stores, Target.com and Nara.com between July 2025 and June 2026); Nara CORE Summary, supra note 1 (Nara initiated a voluntary recall of all lots on the market on June 12, 2026).

^[47] U.S. FDA, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026) (initial June 2026 posting: three confirmed type A infant-botulism cases in California, Pennsylvania, and Washington linked to Nara Organics Whole Milk Organic powdered infant formula, onsets April–May 2026; Organic West Milk and its processor, Dairy Farmers of America, identified as suppliers shared with ByHeart; Organic West Milk’s earlier customer list to FDA was incomplete and omitted Nara Organics), https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026.

^[48] CDC, Investigation Update on Infant Botulism Outbreak, June 2026 (update of July 6, 2026) (four confirmed type A cases: California (2), Pennsylvania (1), Washington (1), all hospitalized and treated with BabyBIG; laboratory testing detected Clostridium botulinum in an open can of Nara Organics formula fed to one of the infants; FDA testing an unopened can from the same lot), https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html.

^[49] Centers for Disease Control and Prevention, Infant Botulism Outbreak Linked to Powdered Infant Formula, June 2026, and its investigation, locations and timeline subpages, update of Aug. 27, 2026, https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/index.html; investigation update at https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html (no new cases added since the July 6, 2026 update; four cases; whole genome sequencing linked a patient sample from this outbreak to a patient sample, product samples, and an ingredient sample collected during the 2025 ByHeart investigation; the formulas sold by both Nara Organics and ByHeart were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America).

^[50] U.S. Food and Drug Administration, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026), update of Aug. 27, 2026, https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026 (one clinical sample from an infant in this outbreak is a genetic match to a clinical sample from an infant in the 2025 ByHeart outbreak, a powdered infant formula base sample from the ByHeart investigation, and four samples of unopened cans of ByHeart powdered infant formula; Nara Organics lots linked to illness were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America; matching WGS results and supply-chain commonalities indicate a common source of contamination; not enough evidence to determine whether milk was contaminated before drying or during the drying process; root cause investigation ongoing); Nara CORE Summary, supra note 1 (CDPH sequenced the open-can isolate and three clinical isolates, California (2) and Washington (1); the Washington clinical isolate was closely related (5 SNPs) to one clinical, one powdered infant formula base and four unopened-can isolates from the 2025 ByHeart investigation; the two California clinical isolates and the open-can isolate were not closely related to existing isolates in the national database; firm placed on Import Alert 40-05 on June 25, 2026 (name redacted); evidence not sufficient to confirm sources and routes of contamination).

^[51] CORE Record, Executive Incident Summary at 3–6, 8–9 (assignments 3–5; Tables 1–2; WGS strains 2 and 11; Traceback Abbreviated Summary); ICS 202, entries of Nov. 25, 2025 (traceback records: liquid whole milk supplied by twenty dairies to Dairy Farmers of America, Fallon, Nev., where it is spray-dried into organic whole-milk powder; Organic West Milk acts as a broker and uses a third-party carrier to deliver the powder), Jan. 21, 2026 (FDA firm call informing Dairy Farmers of America, ByHeart, and Organic West Milk of the positive sample and whole-genome sequencing results), and Feb. 9, 2026 (FDA firm call with Dairy Farmers of America and Organic West Milk on FDA Sample #1319424). U.S. Food and Drug Administration, Coordinated Outbreak Response and Evaluation (CORE) Network, Executive Incident Summary: Clostridium botulinum/Infant Formula/Nov 2025, CARA #1350 (May 1, 2026), released with Incident Objectives (ICS 202, Operational Period #7), Incident Briefing (ICS 201, CORE Incident No. 1350), Human Foods Program Signal Detection & Bioinformatics Branch, WGS Analysis Report: WGS-Report-ByHeart-260224 (Feb. 24, 2026), and Human Foods Program Health Hazard Evaluation, HHE #11418, RES #97959 (Dec. 5, 2025), in response to FOIA Request No. 2026-4033 (redacted under 5 U.S.C. § 552(b)(4), (b)(5), (b)(6) and (b)(7)(D)) [hereinafter CORE Record]; Nara Organics, Nara’s Whole Milk Supply Chain (June 23, 2026), supra note 46 (Nara’s own account: whole milk purchased from Organic West Milk from October 2024 to April 2025, spray dried at Dairy Farmers of America in Nevada, and used in the formula Nara manufactured in Germany and sold in the United States at the time of the outbreak).

^[52] U.S. Food and Drug Administration, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026), update of Aug. 27, 2026, https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026; Nara Organics, August 27 Update (Aug. 27, 2026), https://nara.com/pages/formula-recall-update-august-27-2026 (Nara’s own summary of the FDA sequencing: one clinical sample “clustered with a strain of C. botulinum found in a ByHeart clinical patient sample from 2025, as well as base powder and unopened cans of ByHeart formula powder”; the other two clinical isolates and the open-can isolate matched nothing in the NCBI database).

^[53] CORE Record, Executive Incident Summary at 5–10 (Laboratory Sample Overview, Tables 1–4; WGS analysis; Traceback Abbreviated Summary) (at least seventeen product samples positive for C. botulinum: eight finished-formula, four base-mix, five whole-milk-powder; FDA’s two positives were a base-mix retain from Blendhouse Allerton, Iowa and a powdered-milk retain from Dairy Farmers of America, Fallon, Nevada; a second Dairy Farmers of America milk-powder retain was positive at the New York State Wadsworth Center; strain 11 links two FDA milk-powder isolates, three ByHeart whole-milk-powder isolates, a ByHeart finished-product isolate, an unopened can from an Arizona case household, and a New Jersey clinical isolate at a mean of 7.5 SNPs; strain 2 links a ByHeart finished-product isolate from lot 251261P2 to a second Dairy Farmers of America milk-powder retain at eight SNPs); see also U.S. Food and Drug Administration, Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula (content current as of Sept. 22, 2026), https://www.fda.gov/food/outbreaks-foodborne-illness/post-outbreak-response-activities-clostridium-botulinum-illnesses-associated-consumption-powdered (two isolates from one lot of organic whole milk powder sampled at Dairy Farmers of America matched a clinical isolate and a positive finished-formula sample; no ByHeart facility deficiency identified that could explain the root cause; ongoing root-cause investigation focused on incoming ingredients and the dairy supply chain); Reagan-Udall Report, supra note 7, App. B, slides 9, 13, 16 & 18, at 25, 27–29 (ByHeart presentation: environmental testing at Allerton, Iowa (406 tests) and Portland, Oregon (66 tests), all negative for C. botulinum; one culture-confirmed positive ingredient, whole milk powder; IEH Laboratories found nine C. botulinum positives among 4,675 samples and concluded that the contamination originated from the whole milk powder ingredient, not from ByHeart’s manufacturing processes; FDA whole genome sequencing cluster including one clinical isolate, two closed powdered infant formula samples, and five isolates from the same lot of organic whole milk powder (three tested by ByHeart and two by FDA), including samples collected at Dairy Farmers of America, the processor for Organic West Milk; “Internal, external and FDA investigations identified a common C. botulinum source in whole milk powder”; whole milk powder supplier delisted; entry point into the ingredient not yet established).

^[54] CORE Record, Executive Incident Summary at 4–5 (Field Investigations & Findings, assignments 7–12); ICS 202, entry of Jan. 28, 2026 (“None of the firms identified any infant formula manufacturers as customers that were supplied whole milk powder.”); U.S. FDA, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026) (initial June 2026 posting: three confirmed type A infant-botulism cases in California, Pennsylvania, and Washington linked to Nara Organics Whole Milk Organic powdered infant formula, onsets April–May 2026; Organic West Milk and its processor, Dairy Farmers of America, identified as suppliers shared with ByHeart; Organic West Milk’s earlier customer list to FDA was incomplete and omitted Nara Organics), https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026 (Organic West Milk’s customer list was incomplete and omitted Nara Organics); Nara Organics, Nara Organics Recalls All Lots of Nara Infant Formula Because of Possible Health Risk (company announcement posted by FDA, June 13, 2026), https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nara-organics-recalls-all-lots-nara-infant-formula-because-possible-health-risk (Nara Organics formula distributed from July 2025).

^[55] Associated Press, Companies that supplied dried milk powder linked to botulism outbreak identified, republished by ABC News (Jan. 28, 2026), https://abcnews.go.com/US/wireStory/companies-supplied-dried-milk-powder-linked-botulism-byheart-129650215 (naming Organic West Milk and the Dairy Farmers of America plant in Fallon, Nevada as the source of the botulism-positive milk powder; Dairy Farmers of America statement that the milk powder met all required tests; Bill Van Ryn, an owner of Organic West Milk, stating that the company “didn’t sell organic whole milk powder to any infant formula maker besides ByHeart”).

^[56] Nara Organics, Nara’s Whole Milk Supply Chain (June 23, 2026), https://nara.com/pages/nara-organics-whole-milk-supplier (“When we learned from media reports in early 2026 that Organic West and DFA supplied ByHeart, we immediately began a rigorous review to determine the safety of Nara’s existing formula containing Organic West milk”; “it was determined that Nara formula could stay on the market”; whole milk powder lots did not overlap with ByHeart’s; sulfite-reducing clostridia results ≤10 CFU/g on every batch; “to date, there have been no positive tests or evidence of c. botulinum in Nara’s formula supply chain”).

^[57] Nara Organics, Nara Organics Recalls All Lots of Nara Infant Formula Because of Possible Health Risk (company announcement posted by FDA, June 13, 2026), https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nara-organics-recalls-all-lots-nara-infant-formula-because-possible-health-risk (“To date, Nara infant formula has not tested positive for C. botulinum.”); compare CDC, Investigation Update on Infant Botulism Outbreak, June 2026 (update of July 6, 2026) (four confirmed type A cases: California (2), Pennsylvania (1), Washington (1), all hospitalized and treated with BabyBIG; laboratory testing detected Clostridium botulinum in an open can of Nara Organics formula fed to one of the infants; FDA testing an unopened can from the same lot), https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html.

^[58] Nara Organics, August 27 Update (Aug. 27, 2026), https://nara.com/pages/formula-recall-update-august-27-2026.

^[59] FDA. Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). Content current as of June 3, 2026. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025 (whole-genome sequencing identified 17 distinct strains across patient, product, and ingredient samples in the ByHeart outbreak); CORE Record, Executive Incident Summary at 10 (“[t]he distribution and comingling of ingredients likely contributed to the widespread nature of the contamination”).

^[60] Nara Organics, August 27 Update (Aug. 27, 2026), https://nara.com/pages/formula-recall-update-august-27-2026 (“All their tests on sealed cans of Nara infant formula have returned negative for C. botulinum toxin type A and toxin type B.”); CDC, Clinical Overview of Infant Botulism, supra note 8 (infant botulism results from ingestion of spores that germinate and produce toxin in the intestine); Reagan-Udall Report, supra note 7, at 8–9 & App. D, at 41; FDA, Outbreak Investigation of Infant Botulism: Infant Formula (November 2025), supra note 21 (“a negative test result does not rule out the presence of the bacteria in the product”).

^[61] Nara Organics, Nara’s Whole Milk Supply Chain (June 23, 2026), https://nara.com/pages/nara-organics-whole-milk-supplier (ICMSF-recommended sulfite-reducing clostridia screening at a suggested maximum of <100 CFU/g; all Nara batches ≤10 CFU/g, the limit of detection); Joint FAO/WHO Expert Meeting on Microbiological Risk Assessment (JEMRA) on Powdered Formula for Infants and Young Children, FAO HQ, Rome, Italy, June 15–19, 2026, Summary and Conclusions (issued July 2026) (hygiene indicators such as Enterobacteriaceae monitoring do not replace or reduce the need for pathogen-specific testing during environmental monitoring); Nadala et al., supra note 44; Reagan-Udall Report, supra note 7, at 9 & App. B, slide 11, at 26 (sulfite-reducing clostridia results for C. botulinum PCR presumptive positives: finished product (17), base powder (3) and ingredients (13), all <10 CFU/g; “Results demonstrate limited reliability of SRC by direct plating as an indicator”).

^[62] Letter from Donald A. Prater, DVM, Acting Deputy Comm’r for Food, U.S. Food & Drug Admin., Human Foods Program, to Infant Formula Industry (July 13, 2026), https://www.fda.gov/media/193534/download, at 1 (letter directed to manufacturers, packagers, distributors, exporters, importers, and retailers involved in the manufacture or distribution of infant formula and infant formula ingredients; issued in response to two multistate outbreaks of infant botulism linked to powdered infant formula and to cereulide intoxication associated with a contaminated ingredient; a manufacturer’s responsibility for safety and quality extends to every ingredient, every supplier, and every link in the supply chain).

^[63] Id. at 1–2 (FDA inspected and collected samples at Dairy Farmers of America, Inc., the processor for Organic West Milk, which supplied ByHeart; two samples from one lot of organic whole milk powder matched a clinical sample and an infant formula sample by whole genome sequencing; ongoing root-cause investigation focused on ingredients and their production environments; Organic West Milk also supplied Nara Organics, which voluntarily recalled all lots of its powdered infant formula).

^[64] Id. at 2–3 (reiterating FDA’s March 2023 Letter to the Powdered Infant Formula Industry that suppliers of raw materials or other ingredients that will not receive a lethal treatment at the infant formula manufacturing facility are an extension of the infant formula manufacturing process; production and in-process control obligations under 21 C.F.R. Part 106; food safety plan, preventive control, and supply-chain program obligations under 21 C.F.R. Part 117, including subpart G supplier verification; redundancy risk management plan requirement of section 424(b) of the FD&C Act, 21 U.S.C. § 350m(b)).

^[65] Id. at 3–4 (recall notifications, outbreak investigations, and import alerts may serve as safety signals that an identified ingredient or supplier presents risk; ignoring or downplaying such signals can lead to public health events that could have been avoided; FDA expects manufacturers to act swiftly to assess and address the risk when a contaminated ingredient or supplier concern is identified, whether by FDA or through the manufacturer’s own monitoring).

^[66] Joint FAO/WHO Expert Meeting on Microbiological Risk Assessment (JEMRA) on Powdered Formula for Infants and Young Children, FAO HQ, Rome, Italy, June 15–19, 2026, Summary and Conclusions (issued July 2026) (adding botulinum neurotoxin-producing clostridia to the priority hazard group for powdered formula; finding that dairy ingredients have been demonstrated as a vehicle for such spores resulting in contamination of powdered formula; recommending supplier risk management programs; stating that control starts with on-farm practices; stating that hygiene indicators do not replace or reduce the need for pathogen-specific testing; noting that current consumer preparation recommendations designed for Salmonella and Cronobacter spp. may not be effective against these spores; recommending revisions to CXC 66-2008). The summary notes that a full report will be published by FAO and WHO, and its Annex 2 recommendations carry the disclaimer that they may be updated following availability of risk assessment results.

^[67] Reagan-Udall Report, supra note 7, at 1, 4–5, 7–10, 16, 20–21 & 44 (funding by ByHeart and the International Dairy Foods Association; roundtable of July 13, 2026; illness pathway demonstrated by the recent outbreaks; prevalence data on farms and in the supply chain limited; no standardized detection methods; testing alone cannot ensure quality or food safety; limitations of sulfite-reducing clostridia testing by direct plating; Recommendations 1 and 17; contributors’ inclusion does not represent endorsement).

^[68] U.S. Food and Drug Administration, Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula (content current as of Sept. 22, 2026), https://www.fda.gov/food/outbreaks-foodborne-illness/post-outbreak-response-activities-clostridium-botulinum-illnesses-associated-consumption-powdered (February 2026 surveillance sampling: 48 powdered milk samples from four suppliers to infant formula manufacturers, 46 negative by PCR; two organic nonfat milk powder samples from the same firm positive by PCR, with whole genome sequencing confirming Clostridium sporogenes carrying a gene highly associated with botulinum toxin B1, the two sequences nearly identical, no match to any clinical or non-clinical sequence previously reported, and the powder confirmed not to have been used to manufacture infant formula; continued root cause investigation “including assessment of the supply chain and dairy-based ingredients”; engagement with Cornell University’s Pathogenic Spore Consortium; request that the International Commission on Microbiological Specifications for Foods revisit its publication “Usefulness of testing for Clostridium botulinum in powdered infant formula and dairy-based ingredients for infant formula”; Reagan-Udall report released September 3, 2026); Nara Organics, Nara’s Whole Milk Supply Chain (June 23, 2026), supra note 57 (ICMSF-recommended sulfite-reducing clostridia screening).

Today HHS Secretary Robert F. Kennedy, Jr., standing at a children’s center in Des Moines, announced the first major update to infant formula nutrient standards in nearly thirty years. The FDA issued the first of three planned proposed rules. It would update the requirements for iodine, manganese, vitamin A and vitamin D, reaffirm the requirements for chloride, potassium, selenium and sodium, and ask whether nutrients most manufacturers already add, such as DHA, ARA and L-carnitine, should be required. Comments are due February 26, 2027, in docket FDA-2026-56789. The agency also released another round of chemical contaminant testing, launched an Infant Formula Testing Webpage and a Chemical Contaminants Dashboard, and said it is working toward action levels for certain contaminants under its Closer to Zero initiative.

That is real work, and I want to say so plainly. The nutrient requirements have not had a comprehensive review since 1998. Putting contaminant results on a public dashboard is exactly the kind of transparency I have spent years asking agencies for. Operation Stork Speed and the Make America Healthy Again push forced the first serious federal look at infant formula in a generation. I said that to the Senate HELP Committee in June, and I will keep saying it.

Secretary Kennedy said today that “Parents deserve confidence in every bottle they feed their baby.” I agree. Which is why I read the release twice.

What the release does not say

The subheading says the new testing data “reaffirms safety of infant formula.” The testing it describes is for chemical contaminants. The words Clostridium botulinum do not appear in it. Neither do Cronobacter, Salmonella, nor the word pathogen. Nothing in today’s announcement touches the hazard that actually put American babies in intensive care this year and last.

Since November 2025, fifty-two infants have been hospitalized with botulism after being fed powdered infant formula: forty-eight in the ByHeart outbreak across seventeen states, and four in the Nara Organics outbreak in California, Pennsylvania and Washington. Many were on ventilators. Everyone was treated with BabyBIG, which the State of California prices at $69,300 a dose. Not one of them was hurt by a heavy metal or an outdated vitamin D requirement. They were paralyzed by spores of a soil organism that came in with the milk.

On August 27, CDC closed the Nara investigation and said, without a hedge, that the formula was contaminated with C. botulinum and made infants sick. Whole genome sequencing tied a Nara infant to a ByHeart infant, ByHeart base powder and four sealed cans of ByHeart formula. Both brands were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America. One contamination, two brands, two outbreaks.

And the rule has not moved. Under 21 C.F.R. § 106.55, powdered infant formula makers must test finished product for two organisms, Cronobacter and Salmonella. C. botulinum is not on the list. It was not on the list when the FDA named the organism by genus and species in its March 8, 2023, Call-to-Action letter to the entire powdered formula industry. It was not on the list when the FDA wrote to industry again on July 13, 2026, after both outbreaks, telling manufacturers that their responsibility reaches every ingredient and every supplier. It is not on the list today.

The agency’s own record says testing is needed

The FDA added Cronobacter to the testing list in 2014 on a record of roughly one reported illness a year, because voluntary testing might not be enough for a food that is an infant’s sole source of nutrition. The botulism record is fifty-two hospitalized infants in two outbreaks.

The FDA’s own post-outbreak response page reports that when it sampled 48 powdered milk samples from four suppliers to infant formula makers in February 2026, two came back positive for a Clostridium carrying a gene associated with botulinum toxin. The Reagan-Udall Foundation’s September report, from a roundtable funded in part by ByHeart and the International Dairy Foods Association, found that there is no standardized method for detecting these spores in formula and that the indicator test the industry relies on can miss spores at levels high enough to make babies sick. The FAO/WHO expert group that met in Rome in June added botulinum neurotoxin-producing clostridia to the priority hazards for powdered formula and said dairy ingredients have been shown to carry them.

Letters, roundtables and referrals to international bodies are not a rule. Guidance has been tried twice now, and it has a body count.

No reply to the letters, no reply to the t-shirts

I wrote the House Energy and Commerce Committee in support of H.R. 7867, the Infant Formula Safety Modernization Act, on June 23, with fourteen families’ statements attached, and again on August 28 after CDC confirmed the genetic link. I wrote the Senate HELP Committee on June 29 and again on August 28. Four letters. No reply to any of them. In September, two “For Babies sake, Test for Botulism in Infant Formula” t-shirts, compressed into the shape of a baby bottle, were hand-delivered to every one of the 77 offices on those two committees, and one went to every other member of Congress. H.R. 7867 has sat in Energy and Commerce since its April 29 hearing without a markup.

So, I am going where the rule is actually written.

The petition

I posted a draft citizen petition earlier this month asking the FDA to add botulinum neurotoxin-producing clostridia to the finished-product testing table at § 106.55(e), and, because the organism arrived in a dairy ingredient, to require that each lot of whole milk powder, nonfat dry milk, whey and similar ingredients be tested before it is used. It also asks for one-business-day notice to the FDA of any confirmed positive, a validated test method within 180 days, lot-level records tracing ingredients back to the dryer and the farm, and environmental monitoring as a secondary control. Each request stands on its own so the Commissioner can grant in part what he will not grant in whole. Forty-six parents of twenty-four of the infants are Co-Petitioners.

The comments have made it better. A pediatrician and neonatologist wrote to endorse every request and to add that cans should tell parents the product was tested and found negative. A veteran food microbiologist answered the question I asked about testing raw milk at the dryer: test the fluid milk at the gate, where a low-level contaminant is more evenly mixed and has not yet been diluted across lots, and hold powder from any presumptive-positive tanker until the result is confirmed. Comments close tomorrow, October 30. I will file shortly after.

What I am asking

Of the FDA: you just showed you can open Part 106 and 107 and do the work in phases. Make botulism the next phase. If the agency can review thirty nutrients in three rounds, it can add one organism to a table that has two. And when you update the testing webpage and dashboard you launched today, put the pathogen results there too.

Of readers: the nutrient docket is open until February 26. If you comment, and you should, tell the FDA that a modern infant formula rule has to cover what is in the can as well as what is supposed to be in it. And when my petition is docketed, I will post the number so you can comment there too.

Nutrition matters. So does a baby who can still swallow, hold up his head and breathe on his own. Parents deserve confidence in every bottle, and confidence comes from testing for what has actually hurt babies.

Perhaps I need to order more t-shirts.

A hat tip to Anna Edney at Bloomberg News, who has done as much as any reporter in the country to keep infant formula safety in front of the public, for breaking the news today that the people who ran ByHeart are about to become major players in the store-brand formula business.

According to Edney’s story, a company led by ByHeart co-founders Ron Belldegrun and Mia Funt – a brother and sister who are now CEO and president of MeridianMade, a contract manufacturer – has agreed to buy Perrigo’s infant formula business for up to $175 million. Dublin-based Perrigo makes the store-brand formula sold under retailer labels across the country. Perrigo says the sale, expected to close in the first half of 2027, will let it focus on its consumer self-care products.

Most important for the families: a MeridianMade spokesperson told Bloomberg that ByHeart has been “discontinued” and will not relaunch. ByHeart formula is not coming back.

So, ByHeart is gone for good. The babies it sickened, and their families, are not. Before everyone moves on, here is a reminder of what happened and why.

What Happened

In October 2025, California’s Infant Botulism Treatment and Prevention Program noticed that three infants with suspected infant botulism had all been fed the same powdered formula – ByHeart Whole Nutrition. The signal was hard to miss. ByHeart had roughly one percent of U.S. powdered formula sales, yet of the 36 infants treated with BabyBIG between August 1 and November 10, 2025, who had any powdered-formula exposure, 15 – more than 40 percent – had been fed ByHeart. The FDA’s own internal outbreak record called that “highly unusual.”

It was the FDA, not ByHeart, that asked for the recall: two lots on November 8, 2025, then every ByHeart product on November 11. ByHeart’s own testing soon found Clostridium botulinum in five of 36 unopened cans spanning three lots.

When the CDC declared the outbreak over on February 26, 2026, the final count was 48 infants – 28 confirmed and 20 probable – in 17 states. Every one of them was hospitalized and treated with BabyBIG. Thankfully, none died. But illness onsets ran from December 24, 2023, to November 29, 2025, and ByHeart reported that one positive lot had a production date of November 15, 2024 – meaning contaminated formula was being made and sold nearly a year before the recall. Preliminary CDC data found that about two-thirds of the infants evaluated needed physical therapy or feeding support after they left the hospital. According to the FDA, this was the first botulism outbreak tied to infant formula anywhere in the world since infant botulism was first described about fifty years ago.

Why It Happened

Edney accurately reports that federal inspectors found no evidence ByHeart’s production process caused the outbreak. That is where the story starts, not where it ends. C. botulinum was found in finished formula, in the base mix, and in the organic whole-milk powder ByHeart bought from Organic West Milk, which was spray dried by Dairy Farmers of America in Fallon, Nevada. The FDA sequenced 37 isolates and sorted them into 17 strains. One of those strains tied together a milk-powder retain at Dairy Farmers of America, ByHeart’s own whole-milk powder, its finished formula, an unopened can from an Arizona family, and a sick baby in New Jersey.

Powdered infant formula is not sterile, and heat that kills Salmonella and Cronobacter does not reliably kill botulism spores. Nor did the indicator tests the industry relies on see the hazard – ByHeart itself reported that every sample in which its lab presumptively detected C. botulinum had sulfite-reducing clostridia below the level those tests flag.

None of that lets a formula maker off the hook. The FDA has said for years, and repeated in its July 13, 2026, letter to the entire infant formula industry, that suppliers of ingredients that will not receive a lethal treatment at the formula plant are an extension of the manufacturing process. If you put it in the can and sell it to parents, you own it. And ByHeart’s compliance history was hardly spotless: an FDA Warning Letter at its former Reading, Pennsylvania plant in 2023, and Form 483 inspection findings at its Allerton, Iowa base-powder plant in February 2025 and again in January 2026.

Then there is Nara Organics. When ByHeart recalled its formula, it steered its customers to Nara with a 20 percent discount code in a since-deleted Instagram post. Nara’s formula was made with milk from the same Organic West Milk, spray dried by the same Dairy Farmers of America. During the ByHeart investigation, Organic West Milk gave the FDA a customer list that left out Nara’s manufacturer. In June 2026, Nara recalled all of its whole-milk formula; the CDC closed that outbreak on August 27 with four confirmed infant botulism cases in California, Pennsylvania and Washington, all hospitalized. Whole genome sequencing matched a Nara baby’s isolate to a ByHeart baby, to ByHeart’s base powder, and to four sealed, unopened ByHeart cans. The FDA concluded the matching sequences, and shared suppliers indicate a common source. It still has not said whether the milk was contaminated before or during drying, and its root-cause investigation remains open.

What Comes Next

The outbreaks forced a real response. The FDA’s July 2026 industry letter, a joint FAO/WHO expert meeting that added botulinum-producing clostridia to the priority hazard list for powdered formula, and a Reagan-Udall Foundation roundtable all reached the same conclusion – there is no standardized method to find C. botulinum in formula, and the industry cannot rely on indicator testing to catch it.

Which brings me back to today’s news. Perrigo makes the store-brand formula that a great many families on tight budgets depend on – and Perrigo’s own Wisconsin formula plant received an FDA Warning Letter on the same day in August 2023 that ByHeart did. That business is about to be run by the people who ran ByHeart. Before it was discontinued, ByHeart said it would not resume production without C. botulinum-specific testing of every dairy ingredient and every finished batch. ByHeart will never resume, so that promise was never tested. MeridianMade should make that same commitment, publicly, for every can that leaves the Perrigo plants.

Better yet, safety should not depend on any one company’s promise. That is why I am pushing for required C. botulinum testing of powdered infant formula and its dairy ingredients – both through H.R. 7867 and through the FDA citizen petition I am filing with ByHeart and Nara parents as Co-Petitioners. Public comments on the draft petition are due tomorrow, October 30.

Marler Clark represents families whose babies were hospitalized in both the ByHeart and Nara Organics outbreaks. Executives can sell, buy and rebrand. These families do not get to start over.