ByHeart Whole Nutrition Infant Formula is being recalled in 12 states due to concerns it may be contaminated with Clostridium botulinum, as the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention continue to investigate a multi-state outbreak of infant botulism.

As of November 10, 15 infants who were either fed the formula or exposed to it have developed infant botulism in 12 different states. Those states are: Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. The investigation remains ongoing.

All 15 infants were hospitalized, and no deaths have been reported. Information is available for 14 of those cases, with the illnesses occurring between August 9 and November

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