11/12/2025
"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 s*x 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. "
Please read the below message from the Food & Drug Administration for more information.
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025 #:~:text=The%20CDPH%20IBTPP%20reported%20an,ByHeart%2D%20brand%20powdered%20infant%20formula.
