WASHINGTON (dpa-AFX) - The Centers for Disease Control and Prevention has urged parents to stop using any ByHeart Whole Nutrition infant formula immediately, even if it is mistakenly found for sale in stores or online.
Laboratory tests have shown that the formula is contaminated with botulism spores and can make infants sick, CDC said in an update on the ongoing investigation of infant botulism cases linked to ByHeart infant formula.
After assessing previously reported infant botulism cases in collaboration with the California Department of Public Health's Infant Botulism Treatment and Prevention Program, CDC investigators expanded the outbreak date range to include 10 cases dating back to December 2023.
As of December 10, 2025, a total of 51 sick infants from 19 states have been hospitalized and treated with BabyBIG in this outbreak. No deaths have been reported. Infant botulism happens when a baby swallows Clostridium botulinum spores that grow in the gut and make toxin. Infant botulism often starts with constipation but is usually first noticed as difficulty feeding, a weak and altered cry, and lack of head control.
On November 7, CDC was notified by IBTPP of a concerning increase in infant botulism, typically a rare illness, in infants consuming ByHeart infant formula. 'While we typically expect to see 150-180 individual cases of infant botulism annually, an outbreak of infant botulism is unprecedented,' says Dr. Jennifer Cope, the chief of CDC's the Enteric Diseases Epidemiology Branch. That evening, CDC and the U.S. Food and Drug Administration were already on the phone with ByHeart urging swift action to remove some of their formula from the market. The next day, CDC urged all parents in the U.S. to stop using two lots of ByHeart formula and informed them of the outbreak.
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