Infant formula recall expands as botulism outbreak cases grow

Nov 13, 2025 - 02:54 PM
FDA-warning

ByHeart has expanded its voluntary recall to include all Whole Nutrition Infant Formula cans and Anywhere Pack products amid an investigation by the Food and Drug Administration and other agencies of a multistate outbreak of infant botulism illnesses. The recall was previously limited to certain lots. As of Nov. 11, 15 infants had suspected or confirmed botulism and confirmed exposure to ByHeart Whole Nutrition infant formula, according to the FDA. Cases have been reported by 12 states.   
  
A company notice published by the FDA said that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin, which can cause botulism. All products were proactively recalled to help the FDA and other investigators identify a root cause of the outbreak, which includes testing all batches of formula with an independent third-party laboratory. The FDA said it has been conducting a broader investigation with the Centers for Disease Control and Prevention into a recent spike of 84 infant botulism cases that began in August. The FDA recommended consumers with any ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack products should discontinue use and dispose of them immediately. 

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