On November 20, 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. FDA has received reports that the recalled formula is still being found on store shelves in multiple states, including at Walmart, Target, and Kroger locations, and at Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s, and Star Market locations. FDA is working with state partners and retailers to ensure an effective recall and the immediate removal of these products from store shelves nationwide. 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. The recalled product was sold on online marketplaces and shipped to customers outside the United States. As part of the investigation, ByHeart tested unopened infant formula products retained at its facility. According to ByHeart, third-party laboratory analysis of some of these samples identified Clostridium botulinum. ByHeart states that it will continue to investigate these findings and perform ongoing testing to identify the source of contamination. To date, there are 31 ill babies(8 new), 31 hospitalized, and no deaths. States with Cases are AZ, CA, ID, IL, KY, ME, MI, MN, NC, NJ, OR, PA, RI, TX, and WA.@ https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025?utm_medium=email&utm_source=govdelivery#InternationalDistro
