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Food SafetyLatest headlines

Recalls

Infant Botulism Outbreak Connected to Powdered Formula Sickens 23

ByHeart formula
FDA
November 17, 2025

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, as well as state and local health officials, are investigating a multistate outbreak of infant botulism illnesses connected to ByHeart powdered infant formula.

Nearly two dozen illnesses have been reported between August and November across Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. All cases resulted in hospitalizations, but no deaths have been reported.

ByHeart expanded a voluntary recall from two batches of its Whole Nutrition Infant Formula products to all Whole Nutrition Infant Formula products, including unexpired lots of formula cans and single-serve “anywhere pack” sticks.

“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” says Mia Funt, co-founder and president of ByHeart. “This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve.”

In a statement on its website, ByHeart says consumers have live access to customer support by phone.

KEYWORDS: baby food baby food toxin infant forumula recall

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