WASHINGTON D.C. — Federal health officials are investigating a multistate outbreak of infant botulism potentially linked to ByHeart Whole Nutrition infant formula. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are collaborating with state and local partners after epidemiologic and preliminary laboratory data suggested the infant formula might be contaminated with Clostridium botulinum.

As of November 10, 2025, a total of 15 infants from 12 states have been reported with suspected or confirmed infant botulism and confirmed exposure to ByHeart formula (various lots).

Key Details of the Investigation

Illnesses Reported: The 15 infants were hospitalized, with illness onset dates ranging from August 9 to November 10, 2025. No deaths

See Full Page