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At the 55^th Session of the Codex Committee on Food Hygiene (CCFH), prompted by the ongoing infant botulism outbreak linked to ByHeart formula in the U.S., CCFH decided to initiate work related to the control of Clostridium botulinum in powdered infant formula.

As of December 10, a total of 51 infants are included in the ByHeart formula botulism outbreak. With an expanded case definition, CDC has identified cases that occurred as early as December 2023.

The Safe Food Coalition, comprising seven influential stakeholder groups, has written a letter to FDA, CDC, and Health Secretary Robert F. Kennedy Jr. urging the agencies to take immediate action to protect infant formula, in light of the ongoing ByHeart infant botulism outbreak.

The nationwide infant botulism outbreak associated with ByHeart infant formula has grown to 39 cases in 18 states. All 39 infants were hospitalized; no deaths have been reported.

ByHeart Inc. tested its products and found C. botulinum Type A in five of 36 samples across three lots. As of November 26, the outbreak includes 37 cases of infant botulism spanning 17 states. FDA has published inspection documents for ByHeart production facilities confirming a history of food safety issues.

As of November 19, the number of infant botulism cases linked to consumption of ByHeart formula has grown to 31 across 15 states. ByHeart's testing of its own product has confirmed the presence of Clostridium botulinum.

FDA recently released a warning letter dated September 5, 2025, issued to Fresh and Ready Foods LLC, a ready-to-eat (RTE) foods producer that was implicated in a multi-state, multi-year listeriosis outbreak.

Clostridium botulinum-contaminated ByHeart-brand formula has sickened at least 23 babies across 13 states. FDA inspection reports and warning letters have come to light showing a history of food safety and hygiene violations at the company’s production facilities.

The outbreak of infant botulism linked to ByHeart infant formula has grown to 23 confirmed cases in 13 states. All infants have been hospitalized, with no deaths reported. The company has issued a recall of all formula products sold nationwide.

ByHeart Inc., the infant formula manufacturer implicated in an ongoing, multistate botulism outbreak, has a history of food safety and hygiene violations at its production facilities, as well as an inadequate root cause analysis in previous incident, per FDA inspection records and warning letters.