ByHeart, a next-generation baby nutrition company, announced a voluntary recall of two batches of its Whole Nutrition Infant Formula following notification from the U.S. Food and Drug Administration ( FDA ) about an ongoing investigation into a nationwide outbreak of infant botulism.

The company emphasized that no ByHeart products have tested positive for contamination and that the recall is being conducted out of an abundance of caution. The FDA informed ByHeart on November 7, 2025, that 13 of the 83 reported infant botulism cases since August involved infants who had consumed ByHeart formula at some point.

However, the agency has not established a direct link between any infant formula and the illnesses. ByHeart Co-Founder and President Mia Funt said the company is acting proactive

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