Current Update

November 19, 2025  

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate 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 19, 2025, a total of 31 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 15 states. Laboratory confirmation for some cases is ongoing. For 27 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 13, 2025. All 31 infants were hospitalized. No deaths have been reported to date. For 23 infants with age and 24 with sex information available, they range in age from 16 to 200 days and 11 (46%) 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. Thirty-one infant botulism cases have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.

FDA has received reports that recalled formula is still being found on store shelves in multiple states. FDA is working with state partners and retailers to ensure an effective recall. All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online. This includes all formula cans and single-serve “anywhere pack” sticks.

Additionally, recalled product was sold through online marketplaces and was shipped to customers outside of the United States. Consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in this recall.

As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, the California Department of Public Health (CDPH) preliminarily detected the presence of botulinum neurotoxin type A in a culture of ByHeart powdered infant formula from an opened can (lot 206VABP/251131P2) that was fed to an infant with laboratory confirmed infant botulism. Additional work by CDPH confirmed the identification of the bacterium, Clostridium botulinum type A from the culture.

As part of its onsite inspections, FDA collected and is analyzing samples of unopened product. Analysis is ongoing and results will be provided as they become available.

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.