Infant Botulism Outbreak Linked to Powdered Formula (2025)

Table of Contents

1. What the FDA Did
2. How the Outbreak Was Found
3. The Recall: From Two Lots to Every Product
4. How the Case Count Grew
5. Recalled Formula on Store Shelves and the Warning Letters
6. What the Laboratories Found
7. Infant Botulism: The Background the FDA Gives
8. What the FDA Told Parents and Doctors
9. What the Action Did Not Do
10. Dates and Status as of October 11, 2026
11. After the Outbreak: Root-Cause Work and a Second Outbreak in 2026
12. How It Fits the FDA’s Other Infant Formula Actions
13. Primary Documents
14. Key Research Papers
15. Connections

1. What the FDA Did

This was an outbreak investigation, not a rule. The FDA and the CDC worked with the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP) and with state and local health departments. The FDA’s part was to trace the illnesses to a food, oversee the recall, inspect the factories and ingredient suppliers, test product and ingredient samples, and enforce the recall against stores that kept selling the formula.

On November 8, 2025 the FDA reported 13 infant botulism illnesses in 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2) and Washington. All 13 infants were reported to have been fed the same brand of powdered infant formula. The FDA said it had recommended that the manufacturer conduct a voluntary recall “due to the number of cases, severity of illness, and the strong epidemiological signal,” and that the manufacturer had agreed that day to recall the two lots the sick infants were reported to have consumed.

The recall itself was the manufacturer’s; the FDA’s role was to investigate, to ask for the recall and its expansion, and to enforce its completion.

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2. How the Outbreak Was Found

The signal came from California’s IBTPP. According to the FDA’s November 8 notice, the program reported an increase in type A botulism infections among infants fed this brand of powdered formula between August 2025 and November 2025.

The FDA’s November 11 update gave the numbers the IBTPP shared:

• From August 1 through November 10, 2025, 84 infants nationwide were treated for infant botulism.
• Of those, 36 (43%) had any exposure to powdered infant formula.
• More than 40% of those formula-exposed infants (15) had been fed this one brand.
• The brand made up an estimated 1% of all infant formula sold in the United States.

The FDA wrote that this showed the brand was “disproportionately represented among sick infants,” and that the investigation had not identified any other formula brand or shared exposure posing a risk to infants.

Health officials interviewed caregivers about everything each infant was fed in the month before falling ill, and several states collected leftover formula from the infants’ homes for testing.

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3. The Recall: From Two Lots to Every Product

• November 8, 2025: the manufacturer agreed to recall two lots of its powdered formula, the lots the sick infants were reported to have consumed.
• November 11, 2025: the FDA expanded its warning to all of the brand’s infant formula and requested that the recall be widened. It gave four reasons: the number of ill infants reported to have consumed the product, additional lot codes, new suspected cases, and the preliminary positive sample from California (section 6). The same day the manufacturer expanded its recall to every product it sold nationwide, both cans and single-serve sticks.

The FDA said the formula had been sold online and in stores at major retailers nationwide, including Guam and Puerto Rico, and internationally. According to customer information from an online marketplace that the FDA cites, a limited quantity of the recalled formula was shipped to 21 places outside the United States: Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, the Republic of Korea, Peru, the Philippines, Romania, Singapore, South Africa, Thailand and the British Virgin Islands.

Because the brand was about 1% of U.S. infant formula sales, the FDA stated that the outbreak did not create shortage concerns for parents and caregivers.

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4. How the Case Count Grew

The FDA’s updates counted infants with suspected or confirmed infant botulism and confirmed exposure to the formula (various lots):

• November 8, 2025: 13 infants, 10 states.
• As of November 10: 15 infants, 12 states; illness onsets from August 9 to November 10, 2025; ages 16 to 157 days.
• As of November 14: 23 infants, 13 states.
• As of November 19: 31 infants, 15 states; ages 16 to 200 days.
• As of November 26: 37 infants, 17 states.
• As of December 3: 39 infants, 18 states; illness onsets from August 9 to November 19, 2025; ages 16 to 264 days.

In every update all the infants counted had been hospitalized and no deaths had been reported. No new cases were added after December 10, 2025.

Before declaring the outbreak over, state and local health departments, the IBTPP and the CDC reviewed the medical records of the 51 infants who had at first been included and applied additional case criteria. Three previously reported cases, from three states, were ultimately diagnosed with other illnesses and removed. The final count the FDA gives, as of February 26, 2026:

• Total illnesses: 48 (28 confirmed, 20 probable)
• Hospitalizations: 48
• Deaths: 0
• Last illness onset: November 29, 2025
• States with cases (17): Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington and Wisconsin

“Confirmed” and “probable” follow definitions set out in the CDC’s food safety alert for the outbreak.

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5. Recalled Formula on Store Shelves and the Warning Letters

After the recall covered every product, the FDA kept receiving reports that the formula was still on store shelves. Its November 20 and November 26 updates listed reports from multiple states and from locations of many grocery and big-box chains; its December 3 update still listed reports from five chains.

• December 12, 2025: the FDA sent warning letters to four major retailers “for failing to remove recalled” formula “from their store shelves despite being notified of the recall.” A warning letter is the FDA’s formal written notice to a company of what the agency considers significant legal violations.
• December 15, 2025: the FDA issued a press release reminding the food industry of its legal duties regarding recalls under the Federal Food, Drug, and Cosmetic Act, and asked companies to follow best practices when carrying out recalls — the agency wrote that this is “especially important for recalls involving foods for infants and young children, who are among our most vulnerable populations.”

On November 26, 2025 the FDA also released the inspection reports (Establishment Inspection Reports and Form 483 inspectional observations) from inspections it had completed between 2022 and March 2025 at the manufacturer’s three formula plants. The FDA reported the classification each plant received at its last inspection: one plant, inspected in February 2025, was classified “Voluntary Action Indicated,” with deficiencies in good manufacturing practice (GMP) cited; one, inspected in March 2025, was “No Action Indicated”; and one, inspected in January 2024, was “Official Action Indicated,” also citing GMP deficiencies, with that plant not in operation since September 2023.

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6. What the Laboratories Found

The outbreak was first linked to the formula through epidemiology — which foods the sick infants had in common. Laboratory proof came over the following months:

• November 8, 2025: the California Department of Public Health preliminarily detected botulinum neurotoxin type A in a culture of formula from an opened can that had been fed to an infant with laboratory-confirmed infant botulism. Further work confirmed the bacterium Clostridium botulinum type A from that culture.
• November 19, 2025: the manufacturer reported that it had tested 36 samples of infant formula across three lots and that five tested positive for C. botulinum type A.
• December 23, 2025: the manufacturer publicly reported positive results in six of 36 samples of finished product, taken from two batches that were both in the first recall.
• January 23, 2026: two samples collected by the FDA tested positive for C. botulinum type A. One, from a closed (unopened) container of the formula, matched a clinical isolate from an infant in the outbreak by whole genome sequencing. These samples also matched two isolates from organic whole milk powder, an ingredient of the formula. A second whole milk powder sample, collected by the FDA at a processor for one of the manufacturer’s suppliers and analyzed by New York State’s Wadsworth Laboratory, was a genetic match to the bacterium found in the formula.
• February 26, 2026: two more isolates from one lot of organic whole milk powder, collected by the FDA at the dairy processor for the manufacturer’s milk supplier, matched the same cluster, which by then included two closed formula samples, one clinical isolate and three earlier milk-powder isolates. Two more clinical isolates analyzed by California matched other clusters: one cluster that included the opened-can sample from November, and one that included four isolates from one lot of formula and a sample of the base mix used to make the formula.

Whole genome sequencing (WGS) reads the full DNA of a bacterial isolate, so that isolates from a patient, a product and an ingredient can be compared; a close match is strong evidence that they share a source. The FDA reported that by February 26, 2026, WGS had identified 17 different strains of the bacterium across samples from patients, finished products and ingredients, and that “due to the complexities of Clostridium botulinum and limited scientific evidence currently available, FDA has not yet determined a root cause(s).”

The FDA also explained why testing was slow. The bacterium’s heat-resistant spores need special activation before they can be detected; a preliminary positive needs confirmatory tests; the process can take two or more weeks; and only a limited number of laboratories have the equipment to do it. The FDA added that a negative test result does not rule out the bacterium in a product.

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7. Infant Botulism: The Background the FDA Gives

The FDA describes infant botulism as “a rare but serious illness” caused by toxin from the bacterium Clostridium botulinum. Its spores occur naturally in the environment, including soil and sediments (dust), and can be carried into factories and homes on hands, shoes and other surfaces.

According to the FDA, the spores are generally harmless to older children and adults with mature, healthy digestive systems, but they can pose a life-threatening risk to infants: once swallowed, the spores can grow in a baby’s gut and produce toxin, which interferes with the nervous system.

The FDA lists the first signs as constipation, poor feeding, loss of head control and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. The illness is diagnosed clinically (by a doctor’s examination rather than waiting for a test), and symptoms can take as long as several weeks to appear after the formula is eaten.

The FDA stressed a difference between two kinds of bacteria in formula. Cronobacter and Salmonella do not form spores and are killed by pasteurization. C. botulinum forms a protective spore that survives typical pasteurization and harsh conditions for long periods, which makes it harder to remove from food plants and calls for different prevention and testing strategies.

The site’s page on raw and pasteurized honey covers infant botulism and honey.

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8. What the FDA Told Parents and Doctors

The FDA’s outbreak page carried this public-health guidance, reported here as the agency’s words:

• The FDA advised parents and caregivers to stop using the recalled formula immediately, regardless of any test results, and stated that consumers worldwide should not use it.
• For a child who had consumed the formula and showed signs such as poor feeding, loss of head control, difficulty swallowing or decreased facial expression, the FDA advised seeking immediate medical attention, stating that “botulism can be fatal”; for a child without symptoms, it advised continued monitoring.
• It advised washing items and surfaces that may have touched the formula with hot soapy water or in a dishwasher.
• It told retailers to make sure recalled product, including product returned by customers, was not on their shelves.
• It directed physicians who suspect infant botulism to the California Department of Public Health’s clinical support line, available around the clock for case consultation.

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9. What the Action Did Not Do

• It created no new rule or standard for infant formula. It was an outbreak investigation with recall oversight and enforcement letters, not a regulation.
• It did not establish how the bacteria got into the formula. As of October 11, 2026, the FDA states it has not identified a root cause. Its inspections of the formula plants did not identify any additional factors that could explain the outbreak, and its inspection of the dairy processor likewise did not identify factors that could explain it.
• The FDA did not itself recall the product. The manufacturer conducted the recall at the FDA’s recommendation and request.
• It did not implicate formula in general. The FDA said its investigation had not identified any other formula brand or shared exposure posing a risk to infants, and that the outbreak did not create a shortage.

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10. Dates and Status as of October 11, 2026

• August 9, 2025: earliest illness onset reported.
• November 8, 2025: investigation announced; two-lot recall agreed; preliminary positive from California.
• November 11, 2025: recall expanded to every product of the brand.
• November 26, 2025: earlier plant inspection reports released.
• November 29, 2025: last illness onset.
• December 10, 2025: last date new cases were added.
• December 12, 2025: warning letters to four major retailers.
• December 15, 2025: FDA press release on industry recall duties.
• January 23, 2026: FDA samples and milk-powder isolates matched by WGS.
• February 26, 2026: CDC declared the outbreak over; the FDA’s outbreak investigation ended and it moved to post-outbreak work.
• June 3, 2026: the FDA reported that its inspections of the formula plants were complete and had led to the identification of C. botulinum in a powdered milk ingredient.

Status as of October 11, 2026: the outbreak is over and the outbreak investigation is closed. The recall of every product of the brand remains in place. The FDA’s root-cause investigation, focused on ingredients, is still open; its post-outbreak page was last updated September 22, 2026. No rule has been proposed.

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11. After the Outbreak: Root-Cause Work and a Second Outbreak in 2026

The FDA’s post-outbreak page lists the work that followed:

• Surveillance sampling of powdered milk. In February 2026 the FDA collected 48 powdered milk samples from four suppliers to infant formula makers (12 per supplier). Forty-six were negative by PCR (a DNA-based screening test). Two, both organic nonfat milk powder from the same firm, were positive; sequencing found Clostridium sporogenes carrying a gene highly associated with botulinum toxin B1, which the FDA says “suggests – but does not confirm” that the bacterium could produce toxin under certain conditions. The FDA confirmed that this milk powder was not used to make infant formula, and the sequences matched no earlier clinical or non-clinical sequence.
• International risk work. The FDA advocated for the Joint FAO/WHO Expert Meeting on Microbiological Risk Assessment (JEMRA) to assess spore-forming pathogens, including C. botulinum and Bacillus cereus, in powdered infant formula; supported a Codex Committee on Food Hygiene request to JEMRA to update its advice on Cronobacter and Salmonella in formula; and asked the International Commission on Microbiological Specifications for Foods to consider revisiting its publication on testing for C. botulinum in powdered infant formula and its dairy ingredients.
• Dairy spore research. The FDA engaged with a university-led consortium of academic and industry researchers working on spore-forming bacteria in dairy production.
• July 13, 2026: the FDA sent a letter to the infant formula industry on the risks to weigh when choosing ingredients and ingredient sources, calling for “increased vigilance.”
• September 3, 2026: the Reagan-Udall Foundation released a report on a roundtable, “Applying the Science to Infant Formula,” in which the FDA took part; the FDA says it is reviewing the findings.

A second outbreak. From June through August 2026, the FDA and CDC investigated another multistate infant botulism outbreak, linked to a different brand of organic whole-milk powdered infant formula. The FDA determined that the implicated lots were made with milk from the same organic milk supplier and spray-dried by the same dairy processor as in the 2025 outbreak. One clinical sample from an infant in the 2026 outbreak was a genetic match to a clinical sample from the 2025 outbreak, to a formula base sample from the 2025 investigation, and to four samples of unopened cans of the 2025 formula. The FDA wrote that these results and the shared supply chain “indicate that there is a common source of contamination between the two outbreaks,” while there is “not enough evidence to determine where the milk was contaminated.” The CDC declared that outbreak over as of August 27, 2026, with 4 confirmed cases and no new cases added since July 3. The site has no separate page on the 2026 outbreak.

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12. How It Fits the FDA’s Other Infant Formula Actions

The outbreak came during Operation Stork Speed, which the Department of Health and Human Services and the FDA announced on March 18, 2025 to expand options for “safe, reliable, and nutritious infant formula.” The FDA describes the initiative as building on the increased oversight of the formula industry it has carried out since 2022. Its parts include the first comprehensive review of all infant formula nutrients since 1998 (opened with a request for information in May 2025, comment period closed September 2025), more testing for contaminants in formula, and continued personal importation of formula, a policy first used in 2022.

After the outbreak, the FDA added a further item to Operation Stork Speed: increased testing of infant formula and its ingredients for spore-forming microbial contaminants such as C. botulinum and Bacillus cereus, beginning with the February 2026 powdered-milk sampling described in section 11. On April 29, 2026 the FDA issued results from its increased contaminant testing of infant formula under the same initiative.

The FDA’s own pages contrast this outbreak with earlier formula problems caused by Cronobacter and Salmonella, non-spore-forming bacteria that pasteurization kills. A different kind of formula failure — a missing nutrient rather than a germ — is covered on the site’s page on the 2003 Israeli soy formula thiamine-deficiency outbreak. Among the FDA’s other 2025 actions on food for babies are its action levels for lead in baby food.

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13. Primary Documents

1. U.S. Food and Drug Administration. Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). Updates of November 8, 11, 14, 19, 20 and 26 and December 3 and 17, 2025, and January 23 and February 26, 2026; content current as of 06/03/2026 — FDA outbreak investigation page
2. U.S. Food and Drug Administration. Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula. Content current as of 09/22/2026 — FDA post-outbreak response page
3. U.S. Food and Drug Administration. Operation Stork Speed. Infant Formula program page, content current as of 07/13/2026 — FDA Operation Stork Speed page

This action has no Federal Register notice or public docket: outbreak investigations, recalls and warning letters are not rulemaking, so the FDA’s web pages above are the primary record.

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Key Research Papers

1. Chung CH, Barash JR, Castonguay JL, Penzel-McNamara C, Lee K, Read JS, Padgett KA, Dover N, Judson AJ, Lamere L, Taylor EV, Cope JR, Conrad A, Medford R, Brooks M, Whitlock L, Dykes J, Lúquez C, Bracken JM, Grube SM, Khouri JM (2026). Multistate Infant Botulism Outbreak Associated with Powdered Infant Formula. NEJM Evidence 5(4):EVIDpha2600020 — PubMed PMID: 41739440
2. Nadala C, Themeli E, Forghani F, Ha Y, Han S, Shapovalova A, Roach J, Kim SH, Thorson JLM, Lee JY, Spear M, Buhrman B, Chiu K, Mullane N, Samadpour M (2026). Detection and characterization of Clostridium botulinum isolated from powdered infant formula. Frontiers in Microbiology 17:1800624 — PubMed PMID: 42376575
3. Barash JR, Hsia JK, Arnon SS (2010). Presence of soil-dwelling clostridia in commercial powdered infant formulas. Journal of Pediatrics 156(3):402-408 — PubMed PMID: 20004414
4. Brett MM, McLauchlin J, Harris A, O’Brien S, Black N, Forsyth RJ, Roberts D, Bolton FJ (2005). A case of infant botulism with a possible link to infant formula milk powder: evidence for the presence of more than one strain of Clostridium botulinum in clinical specimens and food. Journal of Medical Microbiology 54(Pt 8):769-776 — PubMed PMID: 16014431
5. Arnon SS, Schechter R, Maslanka SE, Jewell NP, Hatheway CL (2006). Human botulism immune globulin for the treatment of infant botulism. New England Journal of Medicine 354(5):462-471 — PubMed PMID: 16452558
6. Arnon SS, Midura TF, Damus K, Thompson B, Wood RM, Chin J (1979). Honey and other environmental risk factors for infant botulism. Journal of Pediatrics 94(2):331-336 — PubMed PMID: 368301
7. Panditrao MV, Chung CH, Khouri JM, Barash JR, Motter RN, Dover N, Arnon SS (2023). Dual-Toxin (“Bivalent”) Infant Botulism in California, 1976-2020: Epidemiologic, Clinical, and Laboratory Aspects. Journal of Pediatrics 253:8-13 — PubMed PMID: 35977619

The first paper is a published report on this outbreak; the second describes C. botulinum isolated from powdered infant formula. The 2005 paper reports an earlier single case in the United Kingdom with a possible link to formula milk powder, and the 2010 paper reports clostridia found in commercial powdered formulas. The 2006 trial tested human botulism immune globulin as a treatment for infant botulism; the 1979 paper examines honey and other environmental risk factors, and the 2023 paper reviews dual-toxin infant botulism cases in California from 1976 to 2020.

PubMed Topic Searches

1. PubMed: infant botulism and powdered infant formula
2. PubMed: Clostridium botulinum spores in milk powder
3. PubMed: infant botulism epidemiology
4. PubMed: botulism immune globulin in infants

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Connections

• FDA Actions of 2025
• FDA and Regulation
• FDA Action Levels for Lead in Baby Food (2025)
• Cesium-137 in Shrimp and Spice Imports (2025)
• Food Chemical Oversight: GRAS and Post-Market Review (2025)
• Front-of-Package Nutrition Label Proposal (2025)
• Raw vs Pasteurized Honey (Infant Botulism)
• Honey
• The 2003 Soy Formula Thiamine-Deficiency Outbreak
• Pediatrics
• Necrotizing Enterocolitis
• Sodium Nitrite

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