The FDA and CDC, in collaboration with California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of 13 infant botulism illnesses and hospitalizations from 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington. Laboratory confirmation for some cases is ongoing. No deaths have been reported at this time. The CDPH IBTPP reported an increase in botulism type A infections among infants consuming ByHeart powdered infant formula from August 2025 to November 2025. All 13 cases included in this outbreak are reported to have consumed ByHeart-brand powdered infant formula. Officials in several states have collected leftover infant formula for testing. The FDA has been in contact with the firm and has recommended a voluntary recall due to the number of cases, the severity of illness, and the strong epidemiological signal. ByHeart, Inc. agreed to initiate a recall of the two lots of ByHeart Whole Nutrition Infant formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) that were reported to have been consumed by the infants. FDA is continuing to work with the firm to ensure all potentially impacted products are removed from the market. @ https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025?utm_medium=email&utm_source=govdelivery
