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ByHeart Recalls Formula Over Botulism Outbreak

Published 9 November 2025

ByHeart Inc. recalled two lots of its Whole Nutrition Infant Formula on Saturday after federal health officials linked the product to an outbreak of infant botulism that has hospitalized 13 babies across 10 states, according to the U.S. Food and Drug Administration and Centers for Disease Control and Prevention.

The affected lots are 206VABP251261P2 and 206VABP251131P2, both with a use-by date of December 1, 2026. The powdered formula, sold online and in major retailers nationwide, accounts for less than 1 percent of the U.S. infant formula market, officials said. Parents and caregivers who have the product should immediately stop using it, dispose of it or return it to the point of purchase, and clean any surfaces or items that may have come into contact with it using hot, soapy water or a dishwasher.

The outbreak, which began in mid-August, involves infants ranging in age from two weeks to five months. All 13 cases required hospitalization, but no deaths have been reported. California health officials confirmed two cases in their state, as did Texas and Illinois. Single cases occurred in Arizona, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island and Washington....

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