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. ByHeart’s and the FDA’s investigations into the root cause of the outbreak are ongoing, and at this time, the FDA cannot rule out the possibility that contamination may have affected all ByHeart formula products. In response, CDC broadened the case definition to include any infant with botulism who was exposed to ByHeart formula at any time since the product’s release in March 2022. As of December 10, 2025, a total of 51 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 19 states (AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OH, OR, PA, RI, TX, VA, WA, and, WI). Previously, case counts included illnesses from August 1, 2025, onward. With the expanded definition, CDC and state partners identified 10 additional cases that occurred from December 2023 through July 2025. All 51 infants were hospitalized. No deaths have been reported to date. 51 infants have been identified who were fed ByHeart Whole Nutrition powdered infant formula before becoming ill. FDA’s investigation is ongoing to determine the point of contamination. @ https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025?utm_medium=email&utm_source=govdelivery
