What does research say about ByHeart formula and infant botulism?
CDC said lab tests and case data showed that ByHeart formula had the germ and made babies sick. There were 48 cases in 17 states. Lab tests confirmed 28, and 20 were probable. None of the babies died.
In March 2026, CDC said: “Epidemiologic and laboratory data showed that ByHeart Whole Nutrition infant formula was contaminated with C. botulinum and made infants sick.” CDC has said the outbreak is over.
FDA found the germ in a powdered milk ingredient. As of August 2026, FDA was still looking for the root cause.
In August 2026, FDA looked at a second, smaller outbreak: 4 babies who drank Nara Organics formula. It said DNA test results and shared milk suppliers point to a common source of contamination for both outbreaks. FDA has not yet found the root cause.
These agency findings are about the outbreak as a whole. We found no court ruling that ByHeart formula caused any one baby’s illness.