Infant formula contamination concerns
The a2 Milk Company announced a voluntary recall of three batches of its a2 Platinum Premium USA label infant formula on May 2, 2026, due to the presence of cereulide, a heat-stable toxin, with distribution nationally. As of May 29, 2026, the FDA released a report detailing its timeline and traceback findings in the botulism outbreak tied to ByHeart infant formula, suggesting contamination occurred long before the outbreak was identified. This follows a multistate infant botulism outbreak linked to ByHeart formula, which sickened 48 babies, all requiring hospitalization, with the CDC declaring the outbreak over in February 2026. The FDA has issued warning letters to four major retailers for failing to remove recalled ByHeart infant formula from shelves, highlighting ongoing recall management issues.
Timeline
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May 2026 — 2 developments
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 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.
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 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 released a follow-up investigation in March 2026, testing 49 additional infant formulas for heavy metals and other contaminants.
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
The FDA has issued warning letters to four major retailers for failing to remove recalled ByHeart infant formula from their shelves.
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.
State officials in Michigan are still finding recalled ByHeart infant formula on store shelves, months after the product was linked to a botulism 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
The infant botulism outbreak linked to ByHeart formula has concluded, with no new cases reported since mid-December 2025.
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.
A multistate outbreak of infant botulism linked to ByHeart powdered infant formula has been describe…
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.
Investigations reveal that a contaminated ingredient used in infant formula was first supplied in late 2024 and persisted through 2025.
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.
The litigation surrounding the ByHeart infant formula botulism outbreak has expanded with the addition of two new defendants: Organic West, Inc.
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.
The FDA announced it will begin testing infant formula products and ingredients for Clostridium botulinum spores.
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.
The International Baby Food Action Network (IBFAN) is seeking a new Emergency Resolution to protect …
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
One infant, Ashaan Carter, has reportedly suffered severe health consequences due to the contaminated formula, requiring extensive medical care.
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.
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.
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.
An international food standards committee, the Codex Committee on Food Hygiene, supported by 50 memb…
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
The Marler Blog highlighted a 2023 FDA letter that had previously warned infant formula manufacturer…
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.
The FDA issued a letter to the industry emphasizing firms' legal obligations during recalls and anno…
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
The FDA and CDC, along with state partners, are investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant 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.
An infant botulism outbreak linked to ByHeart infant formula began earlier than previously reported,…
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.