FDA opens investigation into ByHeart baby formula after 13 infants sickened with botulism


FDA Launches Urgent Probe Into ByHeart Baby Formula Following Botulism Outbreak Affecting 13 Infants

Thirteen infants have been admitted to hospitals in various states including Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

SAN FRANCISCO — Health officials have issued a caution regarding certain batches of ByHeart baby formula, as a botulism investigation unfolds across multiple states.

These hospitalizations occurred in those 10 states after the infants consumed the formula between August and November, as reported by the U.S. Food and Drug Administration (FDA).

Consumers are advised to avoid using ByHeart Whole Nutrition Infant Formula with the lot numbers 206VABP/251131P2 or 206VABP/251261P2, which have a use-by date of December 1, 2026. These identifying numbers are located on the bottom of the cans.

ByHeart has opted to voluntarily recall these products, which were distributed both online and through major retailers across the nation. According to the FDA, this recall affects less than 1% of the total baby formula available in the U.S., thus it is not expected to lead to a shortage.

The FDA recommends that those in possession of these specific formula lots should mark the can as problematic and dispose of it immediately.

No deaths have been reported at this time and the last documented illness was in November. An investigation into the outbreak is underway. 

Botulism is an illness caused by a toxin that attacks the body’s nerves. It can cause difficulty breathing, muscle paralysis and death in some cases. 

The FDA says infants with botulism may experience constipation, poor feeding, difficulty swallowing which can progress into difficulty breathing and possible respiratory arrest. Infants may also lose the ability to control their heads. 

Symptoms may take weeks to develop after getting botulism, according to the warning. 

Health officials encourage anyone with these symptoms, or who have infants experiencing these symptoms, to contact their health care provider. 

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