FDA Urges Infant Formula Industry to Strengthen Supplier Oversight Following Botulism Outbreaks and Recalls

The U.S. FDA is urging infant formula makers to tighten supplier oversight following recent botulism outbreaks linked to ByHeart and Nara Organics, marking the first U.S. formula-linked botulism cases in nearly 50 years. Additionally, a global cereulide contamination event tied to arachidonic acid oil affected 10 countries. While the FDA's root-cause investigations remain ongoing, the agency is pressing the industry to close critical supply chain gaps and actively monitor safety signals.

FDA supplier oversight letter

• ▪The U.S. Food and Drug Administration sent a letter on July 13, 2026, urging the infant formula industry and supply-chain partners to strengthen oversight of ingredient suppliers.
• ▪The Food and Drug Administration's letter does not announce new regulations, but functions as a direct appeal for the industry to close gaps that allow contaminated ingredients to reach finished products.

ByHeart botulism outbreak

• ▪The ByHeart botulism outbreak resulted in 48 infants being hospitalized and treated with human botulism immune globulin, with cases dating back to December 2023.
• ▪Investigators cultured Clostridium botulinum type A from both opened and unopened cans of ByHeart Whole Nutrition formula, indicating contamination occurred before the product reached families.
• ▪The 2025 ByHeart infant formula botulism outbreak was the first confirmed U.S. botulism outbreak linked to infant formula in nearly 50 years.

Nara Organics botulism outbreak

• ▪The Food and Drug Administration and Centers for Disease Control and Prevention flagged infant botulism risks that led Nara Organics to issue a U.S.-wide recall.
• ▪The Food and Drug Administration investigated a multi-state outbreak of infant botulism associated with Nara Organics powdered infant formula, which resulted in a voluntary product recall.

Cereulide contamination in ARA oil

• ▪A global contamination event from late 2025 through early 2026 resulted in nearly 150 suspected and confirmed cases of cereulide intoxication across 10 countries.
• ▪The cereulide contamination event was traced to contaminated arachidonic acid oil, a common ingredient used in infant formula to approximate breast milk's fatty-acid profile.
• ▪In May 2026, New Zealand's a2 Milk recalled three batches of its a2 Platinum formula sold in the U.S. after detecting the toxin cereulide.

Supply chain control gaps

• ▪The Food and Drug Administration acknowledged there is no single validated approach to controlling spore-forming organisms such as Clostridium botulinum in formula ingredients.
• ▪The Food and Drug Administration expects manufacturers to understand where ingredients originate, how they are produced, what risks they carry, and whether those risks are effectively controlled.

Ongoing root-cause investigation

• ▪The Food and Drug Administration's root-cause investigation into the 2025 and 2026 domestic infant botulism outbreaks is ongoing.
• ▪The Food and Drug Administration has completed initial surveillance work characterizing the prevalence of Clostridium botulinum in powdered milk ingredients, but has not identified how spores entered the supply chain.

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