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ByHeart Baby Formula From All Lots May Be Contaminated with Botulism Bacteria, Tests Show
California investigates six infant botulism cases linked to ByHeart formula before August outbreak; 31 cases confirmed in 15 states, with 107 infants treated using BabyBIG, officials said.
- California health officials opened a probe into pre‑outbreak illnesses linked to ByHeart, investigating six additional infant botulism cases occurring between November 2024 and June 2025, according to CDPH.
- California Department of Public Health noted rising ByHeart use among cases and reported, 'ByHeart usage was becoming more prevalent among cases and CDPH elevated these signals to CDC and FDA,' despite its about 1% market share.
- Lab testing found the bacteria in some samples as laboratory testing of 36 formula samples showed five contained the botulism-causing bacteria, and ByHeart said it cannot rule out contamination across all lots.
- ByHeart expanded its recall on Nov. 11 to include all product, and at least 107 infants nationwide have received BabyBIG treatment since Aug. 1; parents and caregivers should stop feeding the formula and monitor symptoms for up to 30 days.
- The U.S. Food and Drug Administration warned that negative tests don’t rule out Clostridium botulinum in powdered infant formula, spores are widespread, and some recalled cans remain on shelves as cases may rise.
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Leaning Left18Leaning Right6Center59Last UpdatedBias Distribution71% Center
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71% Center
L 22%
C 71%
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