Children's Health Defense Federal investigators confirmed that ByHeart infant formula is at the center of an unprecedented botulism outbreak that sent 51 babies to the hospital in 19 states. The FDA identified botulism-causing bacteria in an unopened can of the formula. ByHeart is a member of the American Academy of Pediatrics’ “President’s Circle” of 10 annual donors that donate at least $50,000 to the organization.
Fifty-one babies in 19 states have been hospitalized with infant botulism after consuming ByHeart Whole Nutrition infant formula, federal officials confirmed last month.
Infant botulism can be fatal, according to the U.S. Food and Drug Administration (FDA). Patients typically initially develop constipation, poor feeding, loss of head control and difficulty swallowing — which can lead to difficulty breathing and respiratory arrest.
Symptoms can take several weeks to develop. No deaths related to ByHeart have yet been reported.
A California program that provides the only treatment for infant botulism was the first to identify a surge in cases among babies who had consumed ByHeart formula.
The FDA has been carrying out a multi-state investigation into an outbreak of infant botulism tied to powdered infant formula since November 2025.
The 51 cases the agency identified were initially believed to have started in 2025. However, as early as December 2023, the investigation identified one case linked to ByHeart’s formula.
In its most recent update, the FDA reported it identified the bacteria that can cause botulism in two samples linked to ByHeart’s formula.
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