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Nationwide Recall of Infant Formula Due to Botulism Outbreak

  • On November 11, 2025, ByHeart expanded its recall to include all ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack sticks nationwide after the U.S. Food and Drug Administration requested it.
  • Laboratory findings and epidemiology indicate California Department of Public Health found Clostridium botulinum in an opened ByHeart formula can, and the CDC linked it to at least 15 infant botulism cases across 12 states.
  • Health officials say at least 84 infants have been sickened, with symptoms appearing within 18 to 36 hours or up to 30 days, according to CDC.
  • On Nov. 12, 2025, families including Stephen and Yurany Dexter and Hanna and Michael Everett filed federal lawsuits against ByHeart, alleging negligence and seeking damages for harm and prior contamination notices in 2022.
  • Additional testing is underway with results expected in the coming weeks; the U.S. Food and Drug Administration previously issued a Warning Letter citing safety issues, while ByHeart, Inc. sells about 200,000 cans per month, raising supply concerns.
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Food Poisoning Bulletin broke the news in on Wednesday, November 12, 2025.
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