Infant formula contamination concerns
The FDA urged infant formula manufacturers to enhance supplier oversight on July 15, 2026, following multiple recalls and recent infant botulism cases, including four hospitalizations linked to Nara Organics Whole Milk Organic Powdered Infant Formula between April and May 2026. As of July 17, 2026, laboratory testing confirmed Clostridium botulinum in an opened can of Nara Organics formula, which was voluntarily recalled on June 13, 2026. This action follows a multistate infant botulism outbreak that affected 48 infants across 17 states, with the FDA identifying Clostridium botulinum in a powdered milk ingredient linked to ByHeart infant formula on June 4, 2026. The FDA expects manufacturers to understand ingredient origins, production, risks, and control effectiveness.
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July 2026 — 3 developments
Infant Botulism Cases Rise to Four Hospitalizations Linked to Nara Organics Formula
As of July 6, 2026, four infants were hospitalized with botulism linked to Nara Organics Whole Milk Organic Powdered Infant Formula, with illnesses occurring between April and May 2026. The FDA is urging manufacturers to improve supplier oversight following this and a previous outbreak linked to ByHeart formula.
FDA Urges Infant Formula Industry to Enhance Supplier Oversight Amidst Botulism Cases
The FDA has issued a letter urging the infant formula industry to enhance supplier oversight and vigilance following multiple recalls and recent infant botulism cases. The agency expects manufacturers to understand their ingredients' origins, production methods, potential risks, and control effectiveness. This action follows investigations into outbreaks linked to specific formulas and a shared dairy-based ingredient supplier.
FDA Confirms Clostridium Botulinum in Recalled Nara Organics Infant Formula
Laboratory testing has confirmed the presence of Clostridium botulinum in an opened can of Nara Organics Whole Milk Organic Powdered Infant Formula. This confirmation follows a voluntary recall initiated on June 13, 2026, due to four suspected cases of infant botulism reported between April and May 2026.
June 2026 — 6 developments
Nara Organics Recalls Infant Formula Amid Potential Botulism Cases
Nara Organics is recalling its Whole Milk Organic Powdered Infant Formula due to three suspected cases of infant botulism under investigation in California, Pennsylvania, and Washington. The formula was distributed nationwide between July 2025 and June 2026. This recall follows a concluded multistate outbreak linked to ByHeart formula and other recalls for potential contamination.
FDA Report: Raw Materials Likely Source of ByHeart Infant Formula Botulism Outbreak
An FDA Establishment Inspection Report released in June 2026 indicated that raw materials were more likely the source of the botulism outbreak than ByHeart's processing equipment. The report also highlighted previous findings of unsanitary conditions. ByHeart confirmed on June 3, 2026, that FDA inspections found no deficiencies, and production resume planning is underway.
FDA Investigating Ongoing Baby Botulism Outbreak Involving Three Companies
An outbreak of baby botulism is ongoing, with the FDA investigating but not yet determining the source or prevention methods. Three companies are implicated in the outbreak, with each company pointing to the others as the source.
Study: Infants in ByHeart Formula Outbreak Required Extended Medical Support
A study presented on April 24, 2026, revealed that many infants affected by the ByHeart formula outbreak required additional physical therapy and medical support post-hospitalization. The FDA's root cause investigations are ongoing, focusing on ingredients, while ByHeart is developing a new testing protocol for *C. botulinum*.
FDA Finds Clostridium Botulinum in ByHeart Formula Ingredient Amid Outbreak Probe
The FDA has identified Clostridium botulinum in a powdered milk ingredient as part of its root cause analysis of the ByHeart infant formula plants. This discovery is linked to the multistate infant botulism outbreak that affected 48 infants across 17 states.
a2 Milk Recalls Formula for Toxin; EU Tightens China Import Controls
The a2 Milk Company has voluntarily recalled three batches of its a2 Platinum Premium USA label infant formula due to the presence of cereulide, a heat-stable toxin. This action was prompted by new guidance from New Zealand's food regulatory authority. Separately, the European Commission has imposed stricter controls on imports of arachidonic acid oil from China following a similar incident involving cereulide toxin in infant formula.
May 2026 — 2 developments
FDA Releases Report on ByHeart Infant Formula Botulism Outbreak Timeline
The FDA released a report on May 29, 2026, detailing its timeline and traceback findings in the botulism outbreak tied to ByHeart infant formula. The investigation suggests the product may have been contaminated long before the outbreak was identified.
a2 Milk Company Recalls Infant Formula Over Toxin Contamination
The a2 Milk Company has announced a voluntary recall of three batches of its a2 Platinum Premium USA label infant formula due to the presence of cereulide, a heat-stable toxin. The recalled product was distributed nationally through the company's website, Amazon, and Meijer stores.
April 2026 — 1 developments
Consumer Reports finds concerning levels of heavy metals and PFAS in infant formulas
Consumer Reports released a follow-up investigation in March 2026, testing 49 additional infant formulas for heavy metals and other contaminants. Some formulas showed potentially concerning levels of inorganic arsenic, lead, and PFAS.
March 2026 — 2 developments
FDA Issues Warning Letters to Four Retailers for Failing to Remove Recalled Infant Formula
The FDA has issued warning letters to four major retailers for failing to remove recalled ByHeart infant formula from their shelves. This action highlights significant recall management issues across the supply chain following the multistate outbreak of infant botulism linked to the formula, which led to a company-wide recall in November 2025.
Michigan officials find recalled ByHeart infant formula on store shelves months after outbreak
State officials in Michigan are still finding recalled ByHeart infant formula on store shelves, months after the product was linked to a botulism outbreak. The Michigan Department of Agriculture and Rural Development reported finding the recalled formula at surplus and distressed food sales locations. All ByHeart infant formula products were recalled in November 2025 after being linked to the outbreak, which the CDC declared over with 48 babies hospitalized.
February 2026 — 6 developments
ByHeart formula botulism outbreak concludes after sickening 48 babies
The infant botulism outbreak linked to ByHeart formula has concluded, with no new cases reported since mid-December 2025. A total of 48 babies were sickened since 2023, all requiring hospitalization, and no deaths were reported. The exact cause of contamination remains unclear, though investigations identified 17 different strains of bacteria in patient samples and formula.
ByHeart expands recall of infant formula after botulism outbreak
A multistate outbreak of infant botulism linked to ByHeart powdered infant formula has been described, with 51 suspected or confirmed cases across 19 states between March 2022 and December 2025, all requiring hospitalization. Lab testing detected botulinum neurotoxin type A and C in formula associated with an affected infant, and whole-genome sequencing showed genetic matches. ByHeart has expanded its voluntary recall to include all Whole Nutrition Infant Formula cans and Anywhere Pack products.
FDA finds Clostridium botulinum in ByHeart infant formula samples
Investigations reveal that a contaminated ingredient used in infant formula was first supplied in late 2024 and persisted through 2025. As of January 23, 2026, two FDA-collected samples tested positive for Clostridium botulinum type A, with one sample being ByHeart powdered infant formula that matches a clinical isolate from an affected infant. These samples also match two isolates of whole milk powder, an ingredient ByHeart uses.
ByHeart infant formula lawsuit expands to include Organic West and Dairy Farmers of America
The litigation surrounding the ByHeart infant formula botulism outbreak has expanded with the addition of two new defendants: Organic West, Inc. and Dairy Farmers of America, Inc. These companies now join ByHeart, Inc. and Target Corporation in the lawsuit, which alleges negligence and breach of warranties.
FDA to test infant formula for botulinum spores after ByHeart outbreak
The FDA announced it will begin testing infant formula products and ingredients for Clostridium botulinum spores. This action is a direct response to the ongoing infant botulism outbreak linked to ByHeart infant formula, which has affected 51 infants across 19 states, all requiring hospitalization.
IBFAN Seeks Emergency Resolution to Protect Infants from Formula Contamination
The International Baby Food Action Network (IBFAN) is seeking a new Emergency Resolution to protect infants from intrinsic contamination in formula, urging governments to update outdated guidelines in light of the ByHeart botulism outbreak.
January 2026 — 3 developments
Ashaan Carter suffers severe health consequences from contaminated formula
One infant, Ashaan Carter, has reportedly suffered severe health consequences due to the contaminated formula, requiring extensive medical care. This detail provides specific insight into the impact on victims beyond general case numbers.
Disparti Law Group Files Federal Lawsuit Against ByHeart Over Infant Botulism Case
A federal lawsuit has been filed against ByHeart by Disparti Law Group on behalf of a family whose infant was hospitalized with botulism after consuming the company's formula.
Food Standards Committee Calls for Botulism Risk Assessment in Infant Formulas
An international food standards committee, the Codex Committee on Food Hygiene, supported by 50 member countries, has called for a scientific risk assessment of botulism spores in powdered infant formulas. This action is a direct result of the ByHeart infant formula botulism outbreak.
December 2025 — 2 developments
Marler Blog highlights 2023 FDA botulism warning to infant formula manufacturers
The Marler Blog highlighted a 2023 FDA letter that had previously warned infant formula manufacturers and distributors about the risk of botulism, providing new context to the current outbreak involving ByHeart products. This pre-existing warning indicates that the risks were known to regulators and the industry before the current incident.
FDA Issues Recall Warning, Announces New Initiative After ByHeart Formula Found on Shelves
The FDA issued a letter to the industry emphasizing firms' legal obligations during recalls and announced a new initiative to improve recall efficiency, after recalled ByHeart infant formula products were found on store shelves weeks after the announcement.
November 2025 — 2 developments
FDA and CDC investigate infant botulism outbreak linked to ByHeart formula
The FDA and CDC, along with state partners, are investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula. As of November 10, 2025, 15 infants across 12 states were hospitalized, with the most recent case reported on November 13, 2025. The agency recommended discarding specific lots of the formula due to contamination with Clostridium botulinum.
ByHeart infant formula linked to botulism outbreak affecting 39 infants nationwide
An infant botulism outbreak linked to ByHeart infant formula began earlier than previously reported, with 15 infants across 12 states affected as of November 11, 2025, all requiring hospitalization. By December 5, 2025, the outbreak had reached 39 infants nationwide, including two in Massachusetts. Despite a voluntary recall, some ByHeart formulas were still found on store shelves.