Overview
- Health officials broadened the case definition to include any infant with botulism who was exposed to ByHeart formula since production began in March 2022, with the latest illness reported on December 1.
- The expanded review added 10 earlier illnesses dating from December 2023 to July 2025 to the outbreak tally.
- ByHeart withdrew all U.S. products on November 11 after reporting independent lab findings of 36 positive samples from three lots for bacteria capable of causing infant botulism.
- FDA inspectors visited ByHeart facilities in Iowa and Oregon, and prior records cite contamination issues and a 2023 Reading, Pennsylvania, plant shutdown for mold, leaks and insects.
- No deaths have been reported, and affected infants are being treated with BabyBIG, a scarce plasma-derived therapy produced in small batches.