ByHeart voluntarily recalls infant formula amid nationwide infant botulism reports

Baby nutrition company ByHeart has voluntarily recalled two batches of ByHeart Whole Nutrition Infant Formula.

According to the Food and Drug Administration, on November 7, 2025, the FDA informed ByHeart of approximately 83 reported cases of infant botulism across the United States since August 2025. Among these cases, 13 infants had reportedly consumed ByHeart formula at some point. The FDA has not found any direct connection between infant formula and the reported cases, and there is no historical evidence of infant formula being a cause of infant botulism.