11/12/2025
The FDA and CDC are investigating an outbreak of infant botulism cases among babies who consumed ByHeart infant formula. ByHeart recalled all their formula products sold nationwide on Tuesday morning. While it sounds alarming, and botulism is a very serious diagnosis, no other formulas are known to be impacted.
“Baby formula made and sold in the United States is tightly regulated and safe. ByHeart is a smaller manufacturer, and this recall will not cause any shortages across the country,” said Dr. Steven Abrams, former chair of the AAP Committee on Nutrition and member of the Section on Neonatal-Perinatal Medicine. Learn more:
The Food and Drug Administration recommended a full recall after 15 infants in 12 states had been hospitalized and treated for suspected or confirmed cases of infant botulism since mid-August.