The FDA, the agency that regulates drugs in the United States; The U.S. Centers for Disease Control (CDC) and other local health authorities are investigating cases of botulism in infants in the United States associated with ByHeart infant formula. As of December 10, the outbreak included 51 babies with suspected or confirmed infant botulism in 19 states.
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The investigation also covers 10 cases that occurred between December 2023 and July 2025 and authorities have further extended the period to include cases that occurred since March 2022, when the product was launched on the market. Epidemiological and laboratory data show that ByHeart Whole Nutrition infant formula is contaminated with Clostridium botulinum and has caused illness in infants.
Infant botulism occurs when a baby ingests Clostridium botulinum spores which grow in the intestine and produce a toxin. Most babies with infant botulism initially present with constipation, difficulty feeding, loss of head control, and difficulty swallowing, which may progress to difficulty breathing and respiratory arrest. Symptoms may take several weeks to develop after taking the formula.
The babies’ ages range from 16 to 264 days, of which 22 (43%) are female. All were hospitalized and treated. No deaths have been reported. However, botulism can be fatal if not treated in time.
The FDA reported that all products in the ByHeart Whole Nutrition Infant Formula line have been recalled from the market. This includes all batches of formula cans and individual sachets.
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