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Formula Company Linked to Botulism Outbreak Stopped Pa. Production in 2023

All 23 infants hospitalized after consuming ByHeart formula; the product represents about 1% of U.S. formula sales, health officials said.

  • On Nov. 14, the FDA and CDC linked 23 infants across 13 states to ByHeart's recalled formula, advising parents to stop use immediately.
  • Federal notices say the cases follow a national recall from Nov. 11, and ByHeart, which makes about 1% of U.S. formula, is under investigation by the FDA and CDC.
  • Each affected infant was hospitalized, including the Kentucky case, with symptoms such as constipation, poor feeding, droopy eyelids, and trouble latching or swallowing, Dr. Lamar Davis said.
  • Officials say the recall does not threaten the nationwide baby formula supply, and no infant deaths have been reported as of Nov. 14.
  • Local health departments announced testing to determine diagnoses, and Dr. James Miller, TPHD Officer, urged parents and guardians to seek emergency care if symptoms develop.
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WLKY broke the news in Louisville, United States on Monday, November 17, 2025.
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