Ars Technica6/6/2026Health4 min readUnited States
FDA Investigation into Infant Botulism Outbreak Falls Short of Identifying Root Cause
Quick Look
- The FDA's investigation into a botulism outbreak linked to ByHeart's infant formula, which sickened 48 infants across 17 states, failed to determine the source or root cause of contamination despite tracing the bacteria to ingredients.
- Three companies involved (ByHeart, Organic West, Dairy Farmers of America) deny responsibility.
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The Food and Drug Administration this week posted what critics call an “underwhelming” epilogue to the devastating outbreak of botulism in babies, which was linked to spore-contaminated formula made by ByHeart. Despite clear tracking of the contamination, the regulator still doesn’t know how the bacteria arrived in the formula—or how to prevent it from happening again. [...] ByHeart said it is working to resume infant formula production and is developing more sensitive testing for C. botulinum.
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This article was originally published by Ars Technica.
