CDC Rapidly Responds to First Infant Botulism Outbreak Linked to Formula

The CDC swiftly responded to the first-ever outbreak of infant botulism linked to ByHeart infant formula, demonstrating rapid public health action. As of December 10, 2025, 51 infants across 19 states were hospitalized and treated, with no deaths reported. Infant botulism, caused by Clostridium botulinum spores in the gut, can present as feeding difficulties, weak cry, and lack of head control.

Upon noticing a rise in cases, CDC and FDA quickly coordinated with ByHeart to remove formula from the market and issued immediate guidance to parents. Ongoing laboratory testing and real-time data evaluation exemplify how rapid response, clear communication, and cross-agency collaboration protect vulnerable populations. Read more from the CDC here.