Two batches of ByHeart Whole Nutrition Infant Formula have been recalled as part of an ongoing investigation into infant botulism cases. According to the Food and Drug Administration, the recall was voluntarily initiated by ByHeart, a baby nutrition company.

The FDA contacted the company last week to notify it of an estimated 83 cases of infant botulism having been reported nationwide since August 2025. Of those 83 cases, 13 of the hospitalized infants received ByHeart formula at some point. However, testing of ByHeart products conducted to this point has been negative for contaminants.

“The safety and well-being of every infant who uses our formula is our absolute highest priority,” said Mia Funt, ByHeart co-founder and president. “We take any potential safety concern extremely seriousl

See Full Page