The FDA and CDC, in collaboration with CDPH IBTPP, and state and local partners, are investigating a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.
As of November 10, 2025, a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula (various lots) have been reported from 12 states (see map). Laboratory confirmation for some cases is ongoing. For 14 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 10, 2025. All 15 infants were hospitalized. No deaths have been reported to date. For 14 infants with age and sex information available, they range in age from 16 to 157 days and 7 (50%) are female.
State and local public health officials are interviewing caregivers about the foods the infants were fed in the month before they got sick. Fifteen infant botulism cases have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.
According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Among them, 36 (43%) had any powdered infant formula exposure. Notably, more than 40% (15) infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula. This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants.
As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in an open can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism. Additional testing is underway, and results are expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product.
FDA has been in contact with the firm and has requested a recall expansion to include all ByHeart infant formula on the market. On November 11, 2025, ByHeart expanded its recall to include all ByHeart formula nationwide, including cans and single-serve sticks. This advisory will be updated as additional information becomes available.
FDA’s investigation is ongoing to determine the point of contamination. This advisory will be updated as information becomes available.