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ByHeart Formula Faces Lawsuits After Babies Sickened With Botulism
At least 31 infants in 15 states fell ill from botulism linked to ByHeart formula, prompting multiple lawsuits and ongoing federal investigations into contamination.
- WEDNESDAY, Nov. 26, 2025 — ByHeart, infant formula maker, confirmed lab tests found Clostridium botulinum spores and reported at least 31 infants in 15 states developed suspected or confirmed botulism.
- Federal regulators say the U.S. Food and Drug Administration cited water leaks and raised concerns about bacterial contamination at ByHeart's Pennsylvania facility, which the company says was not involved in the recall; formula makers must follow strict cleanliness rules despite no routine Clostridium botulinum testing.
- All of the affected infants were hospitalized, with many needing feeding tubes and IV therapy; Piper, daughter of Hanna Everett, was hospitalized on Nov. 9 and received botulism antitoxin flown in since hospitals do not stock it.
- Several families have sued ByHeart alleging its formula caused botulism, while federal investigators probe the outbreak and ByHeart focuses on recall and root-cause investigation.
- Public-Health agencies advise parents and caregivers to stop using ByHeart formula and monitor babies for symptoms, as experts say this is the first U.S. botulism outbreak linked to infant formula.
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Infant formula recalled due to botulism risk
CONCORD — The New Hampshire Department of Health and Human Services (DHHS) Division of Public Health (DPH) advises parents and caregivers not to use certain lots of ByHeart Whole Nutrition Infant Formula. The company has voluntarily recalled the products because…
Coverage Details
Total News Sources24
Leaning Left5Leaning Right3Center7Last UpdatedBias Distribution47% Center
Bias Distribution
- 47% of the sources are Center
47% Center
L 33%
C 47%
R 20%
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