FDA report shows timeline, traceback in infant botulism outbreak traced to ByHeart formula
In its Executive Summary, the FDA redacted the name of the company that provided ByHeart with some of the powdered milk used in the production of the implicated formula.
An Executive Summary from FDA regarding the botulism outbreak tied to ByHeart infant formula suggests the company’s product was contaminated long before the outbreak was identified.
The outbreak sickened 48 infants across 17 states. All were hospitalized. The outbreak was not identified until November 2025 when California public health officials noticed a cluster of botulism cases among infants.
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