In a significant health alert, the Food and Drug Administration (FDA) has expanded its recommendation regarding ByHeart Whole Nutrition Infant Formula due to a concerning outbreak of infant botulism. The agency now advises the recall of all unexpired lots of ByHeart infant formula, including cans and single-serve sticks. This decision follows reports of illnesses in infants who have consumed the product, alongside new cases of suspected infant botulism.
As of November 10, 2025, fifteen infants across twelve states have been reported to have suspected or confirmed cases of botulism, all linked to ByHeart’s formula. These infants were hospitalized, but fortunately, no fatalities have been reported. Symptoms of infant botulism can initially include constipation, poor feeding, loss of head control, and difficulty swallowing, potentially escalating to severe respiratory issues.
The FDA and the Centers for Disease Control and Prevention (CDC) are coordinating their efforts with the California Department of Public Health (CDPH) and other local partners to investigate the outbreak. Epidemiological data suggests that ByHeart’s formula may be contaminated with Clostridium botulinum, the bacterium responsible for botulism. Investigations have confirmed a significant presence of this formula among infants affected by the illness, despite ByHeart accounting for less than 1% of the infant formula market in the United States.
Parents and caregivers are urged to stop using any ByHeart products immediately and to seek medical attention if their infants exhibit symptoms related to botulism. For those who have consumed the formula but are not currently showing symptoms, careful monitoring is recommended. It is advised to retain any formula containers for potential testing by health officials should symptoms develop later.
Additionally, health departments in various states are conducting interviews with caregivers to gather information about the diets of affected infants prior to their illnesses. As part of the ongoing investigation, state officials have begun testing leftover formula for contamination.
Recent laboratory tests conducted by the CDPH indicated the presence of botulinum toxin in an open can of ByHeart formula that had been fed to an infant that subsequently developed botulism. This prompted the FDA to request an expansion of the recall, which ByHeart agreed to, affecting all their formula products available on the market.
The investigation is ongoing, with health authorities working to determine the exact point of contamination. They will continue to provide updates as more information becomes available, and families are advised to remain vigilant regarding their infants’ health.
