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The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have reported that eight additional infants have been hospitalized due to an outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula. This brings the total number of hospitalized infants to 31 across 15 states, as of Wednesday (November 19).
The outbreak involves the bacterium Clostridium botulinum, which can cause severe illness in infants. Symptoms include constipation, poor feeding, and difficulty swallowing, which can progress to respiratory difficulties. The outbreak investigation is ongoing, with the CDC, FDA, and the California Department of Public Health working together to trace the source of contamination.
ByHeart Inc. has voluntarily recalled all batches of its Whole Nutrition infant formula, urging parents and caregivers to stop using the product immediately. The recall includes all unexpired lots of formula cans and single-serve "anywhere pack" sticks. Despite the recall, reports indicate that some products remain on store shelves, prompting the FDA to work with state partners and retailers to ensure effective removal.
The FDA emphasizes that the outbreak does not pose a risk of formula shortages, as ByHeart products account for only 1% of the U.S. market. However, the recall affects products sold both online and in stores nationwide.
Parents and caregivers are advised to seek immediate medical attention if their infant shows symptoms of botulism. No deaths have been reported in connection with the outbreak, and further testing is underway to confirm the presence of Clostridium botulinum in the formula.