WASHINGTON - Federal health officials are advising parents and caregivers to stop using specific lots of ByHeart Whole Nutrition Infant Formula due to an ongoing investigation into a multistate outbreak of infant botulism.

The outbreak includes cases in Pennsylvania and nine other states, according to a November 8, 2025, update from the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC).

The company, ByHeart, Inc., has agreed to voluntarily recall two specific lots of the powdered formula that were reportedly consumed by the affected infants:

Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")

Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")

The lot code and "Use by" date can be found on the bottom of the infant formula can.

Officials report 13 illnesses ac

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