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US FDA Updates Investigation into Infant Botulism Linked to ByHeart Infant Formula

Dec 16, 2025
Rita Bao
A total of 51 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula have been reported across 19 US states. All ByHeart infant formula products, including cans and single-serve “anywhere pack” sticks, have been recalled, and FDA is working with retailers to ensure complete removal from the market.

On December 10, 2025, the U.S. Food and Drug Administration (FDA) released an update regarding the ongoing investigation into a multistate outbreak of infant botulism associated with ByHeart Whole Nutrition infant formula. Epidemiologic and laboratory data indicate that the product may be contaminated with Clostridium botulinum. which is causing infant illness in multiple regions of the country.

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Tags : Infant FormulaFood SafetyContaminantsUSFood Safety Incidents
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