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May 29, 2026 · Industry Watch

FDA Traces Infant Botulism Outbreak to ByHeart Formula

FDA Traces Infant Botulism Outbreak to ByHeart Formula
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A new report from the FDA outlines the timeline and traceback process regarding contaminated infant formula.

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The FDA has released an Executive Summary detailing the investigation into an infant botulism outbreak linked to ByHeart formula. The report provides a comprehensive timeline of the events and the traceback process used to identify the source of the contamination.

According to Food Safety News, the FDA has redacted the identity of the specific company that supplied some of the powdered milk used in the production of the affected formula.

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