The U.S. Centers for Disease Control and Prevention (CDC) is alerting medical and public health partners to a multistate outbreak of infant botulism associated with ByHeart powdered infant formula. This advisory provides updated epidemiologic information, guidance for early case identification, and critical actions for clinicians, hospitals, and public health agencies.

CDC has identified 15 infants with suspected or confirmed infant botulism across 12 states, all of whom required hospitalization and treatment with BabyBIG® (Botulism Immune Globulin Intravenous). While no deaths have been reported, new national data reveal a disproportionate number of illnesses among infants who consumed ByHeart Whole Nutrition formula, prompting an immediate nationwide recall of all ByHeart Whole Nutritio

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