Contaminated milk powder likely source of ByHeart baby formula botulism outbreak: FDA

South China Morning PostEN 1 min read 100% complete by Associated PressJanuary 24, 2026 at 02:10 AM

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The FDA is investigating ByHeart infant formula as a potential source of a botulism outbreak that has sickened numerous babies. FDA testing found bacteria capable of causing botulism in samples of ByHeart formula and in organic whole milk powder used in its production. Specifically, the bacteria found in an unopened formula tin matched a sample from a sick infant, and also matched contamination in the milk powder. Contamination was also detected in a sample of whole milk powder supplied to ByHeart, matching the bacteria in a finished formula sample. While these findings are not conclusive, the FDA is continuing its investigation to pinpoint the exact source of the contamination. A ByHeart official acknowledged the findings as significant for the company.