In the summary, the FDA redacted the name of the company that supplied ByHeart with some of the infant formula used in the production of the related infant formula.
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The FDA’s summary of the botulism outbreak associated with ByHeart infant formula suggests that the company’s products were contaminated long before the outbreak was identified.
The outbreak has infected 48 infants across 17 states. All were hospitalized. The outbreak was not confirmed until November 2025, when California public health officials discovered a cluster of botulism cases among infants.
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