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.
Although the official number of infant botulism cases included in the ByHeart infant formula outbreak remains at 31, the unusual spike in infant botulism treatments recorded by the California Department of Public Health has grown to more than 100, and several babies with exposure to ByHeart formula were treated for botulism as early as November 2024, months ahead of the spike in illnesses.
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.
Clostridium botulinum-contaminatedByHeart-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.
The Reagan-Udall Foundation has published a report that captures key insights from stakeholder discussions on ways to improve U.S. infant formula safety and regulation, which were held to support FDA’s “Operation Stork Speed” efforts.
As of November 11, 15 infants have been hospitalized with botulism in 12 states after consuming ByHeart-brand powdered infant formula. The 15 infants who were confirmed to have consumed ByHeart are part of a broader outbreak comprising 84 total cases. A recall has been issued.
The final Make America Healthy Again (MAHA) Report was unveiled in a September 9 press conference led by HHS Secretary Robert F. Kennedy Jr. Food safety, consumer, and environmental stakeholder groups criticize the report’s deregulatory approach and lack of enforceable actions.
