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 26, 2025, a total of 37 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 17 states (AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OR, PA, RI, TX, WA, and, WI). Laboratory confirmation for some cases is ongoing. Of 36 cases with illness-onset information available, illnesses began on dates ranging from August 9 to November 19, 2025. All 37 infants were hospitalized. No deaths have been reported to date. State and local public health officials are interviewing caregivers about the foods infants were fed in the month before they became ill. Thirty-seven infants have been identified who were fed ByHeart Whole Nutrition powdered infant formula before becoming ill. FDA has received reports that recalled formula is still being found on store shelves in multiple states, including at multiple Walmart, Target, and Kroger locations, and at one or more Sprouts Organic Market, Safeway, Acme, Jewel-Osco, Shaw’s, Star Market, Smith’s, King Sooper’s, Albertson’s, Whole Foods, Wegman’s, and Publix locations. The FDA’s investigation, including onsite inspections, is ongoing to determine the point of contamination. ByHeart, Inc. is the parent company of three Blendhouse manufacturing facilities in Allerton, Iowa; Portland, Oregon; and Reading, Pennsylvania. @ https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025?utm_medium=email&utm_source=govdelivery
