Overview
- CDC’s updated case definition now includes any infant botulism illness with ByHeart exposure since March 2022, adding ten earlier cases identified between December 2023 and July 2025.
- FDA says it cannot rule out contamination across all ByHeart formulas ever made, after independent testing detected the botulism-linked bacterium in 36 samples across three lots.
- ByHeart recalled all U.S. products on November 11, the most recent illness was reported December 1, and no deaths have been reported.
- FDA inspectors visited ByHeart’s production site in Iowa and packaging facility in Oregon last month, and past records cite a 2022 Cronobacter-related lot withdrawal and a 2023 warning letter tied to facility problems.
- Hospitals are treating affected infants with BabyBIG, the donor-derived antitoxin that California officials estimate is stocked through next summer, while families pursue federal lawsuits against ByHeart.