Key Takeaways

Now 15 infants across 12 states have been hospitalized with botulism after consuming ByHeart baby formulaByHeart has expanded its voluntary recall to include all of its baby formula productsParents and caregivers are urged to discard all ByHeart formula and closely monitor any infant who has consumed it

WEDNESDAY, Nov. 12, 2025 (HealthDay News) — ByHeart Inc. has announced a full recall of all its Whole Nutrition Infant Formula products due to concerns about potential contamination leading to infant botulism.

To date, the outbreak has affected 15 babies in 12 states.

The decision to expand the recall was made late Monday after the U.S. Food and Drug Administration (FDA) informed the company of two additional cases of infant botulism in babies who had consumed the formula.

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