ByHeath Botulism Infant Formula – 51 Sick and Hospitalized

As of December 17, 2025, this outbreak includes 51 infants with suspected or confirmed infant botulism from 19 states. Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from December 24, 2023, through December 1, 2025.

All 51 infants were hospitalized and treated with BabyBIG®. No

Chair Cassidy Raises Concerns on Infant Formula Safety, Impact on Children’s Health

WASHINGTON – U.S. Senator Bill Cassidy (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, demanded answers from ByHeart for selling potentially unsafe infant formula that infected 51 infants across 19 states with infant botulism.

“Ensuring that parents and their

Historical associations between powdered infant formula and pathogens such as Cronobacter spp., Salmonella, and Clostridium botulinum should be considered when designing and implementing controls for the safe manufacture of all foods for infants and young children.

In a letter from the FDA – Infant Formula Manufacturers, Packers, Distributors, Exporters, Importers, and Retailers