The FDA has expanded its recommendation to include all ByHeart infant formula products due to the number of ill infants reported to have consumed ByHeart infant formula products and the identification of additional lot codes. ByHeart infant formula products make up less than 1% of all infant formula sold in the US, and this outbreak does not create shortage concerns for parents and caregivers. ByHeart infant formula is available for sale online and at major retailers nationwide. 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 (AZ, CA, IL, KY, MN, NC, NJ, OR, PA, RI, TX, and WA). Laboratory confirmation for some cases is ongoing. All 15 infants were hospitalized. No deaths have been reported to date. According to the Infant Botulism Treatment and Prevention Program (IBTPP), 84 infants nationwide received treatment for infant botulism from August 1, 2025, through November 10, 2025. Notably, more than 40% (15) of infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula. This information shows that the ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart accounts for an estimated 1% of all infant formula sales in the United States. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of 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.@ https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025?utm_medium=email&utm_source=govdelivery
