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FDA Warns Retailers After ByHeart Formula Botulism Outbreak

12/18/2025

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FDA Warns Retailers
  • The U.S. Food and Drug Administration issued warning letters to Walmart, Target, Kroger, and Albertsons over ByHeart infant formula linked to a botulism outbreak.
  • The recall began on November 11 and has hospitalized 51 infants across 19 states.
  • Investigators found recalled ByHeart products still on shelves weeks after the recall, raising safety concerns.
  • The FDA gave 15 days to respond, and ByHeart is offering refunds for recalled products.
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