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Infant botulism in 10 US states linked to formula being recalled

  • On Saturday, ByHeart Inc. agreed to a federal recall of two lots of Whole Nutrition Infant Formula after 13 infants were hospitalized across 10 states, the FDA said.
  • The FDA said it is investigating how contamination occurred and whether other products were affected, noting 13 of the 83 reported cases since August involved infants who consumed ByHeart formula though no direct link was found.
  • The recall affects batch codes 251261P2 and 251131P2 with use-by date December 1, 2026 and UPC 5004496800; ByHeart Co-Founder and President Mia Funt said no spores or toxins were found and replacements are offered.
  • Parents are urged to seek immediate medical care for symptoms including poor feeding, loss of head control, and difficulty swallowing, record lot numbers before discarding formula, clean affected items, and report illnesses via the FDA MedWatch reporting system.
  • The CDC reported the product accounted for an estimated 1% of national formula sales, and ByHeart pledged cooperation with the FDA amid recent shortages and recalls.
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Preliminary tests find germ that causes botulism in ByHeart baby formula

California health officials say tests showed that ByHeart baby formula linked to a botulism outbreak contained the type of bacteria that produces the toxin that has sickened at least 13 infants in 10 states. No deaths have been reported. The…

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Bloomberg broke the news in United States on Saturday, November 8, 2025.
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