Data for the update of December 17, 2025. Epidemiologic and laboratory analyses indicate that ByHeart Whole Nutrition infant formula is the source of this multistate outbreak of infant botulism. Since the last update on December 10, 2025, reports of cases linked to this outbreak have slowed, and public health officials have not added any new cases to this investigation. CDC will provide updates on this outbreak investigation when new information becomes available. FDA will continue to provide investigational updates as needed. All ByHeart infant formula products have been recalled and should not be available for sale in stores or online. This includes all formula cans and single-serve “anywhere pack” sticks. On December 12, 2025, the FDA sent a warning letter to four major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall. On December 15, 2025, the FDA issued a press release and reminded the industry of its legal duties regarding food recalls under the Federal Food, Drug, and Cosmetic Act. Additional testing by ByHeart, the FDA, CDC, and state partners is underway, and results are expected in the coming weeks. Currently, there are 51 total illnesses, 51 hospitalizations, and no deaths. Last Illness Onset: December 1, 2025
States with Cases: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OH, OR, PA, RI, TX, VA, WA, WI. @ https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025?utm_medium=email&utm_source=govdelivery
