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CDC Probes Infant Botulism Outbreak Linked to ByHeart Formula: 23 Infants in 13 States as of November 14, All Hospitalized, No Deaths

Saturday, November 14, 2026 · Medical · GSM News

The Centers for Disease Control and Prevention (CDC), together with the U.S. Food and Drug Administration (FDA) and public health officials in several states, is investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula.

The investigation was announced on November 8, when 13 infants with suspected or confirmed infant botulism had been reported from 10 states, all of whom had been fed ByHeart formula. On November 8, the California Department of Public Health Infant Botulism Treatment and Prevention Program preliminarily detected botulinum toxin type A in a culture from an opened can of the formula consumed by an infant with confirmed botulism. On November 11, as new cases emerged, the FDA expanded its recall recommendation to all ByHeart infant formula products, after the company had first recalled two lots.

As of November 14, the outbreak included 23 infants in 13 states. The CDC said all 23 infants were hospitalized and treated with BabyBIG, and no deaths have been reported. The CDC National Botulism Surveillance System records approximately 150 to 180 infant botulism cases each year. The investigation is ongoing; no other infant formula brands or shared exposures posing a risk have been identified, and the FDA does not anticipate formula shortages as a result of the outbreak.

Source: Centers for Disease Control and Prevention

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Photo: 图中是位于亚特兰大的美国疾病控制与预防中心(CDC)总部大楼。Wikimedia Commons / Centers for Disease Control and Prevention, Public domain

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