Several cases of infant botulism have been linked to a recall of ByHeart Whole Nutrition Infant Formula, according to health officials. The U.S. Food and Drug Administration (FDA) announced the voluntary recall of two specific lots of the formula after 13 infants from 10 states were hospitalized with botulism symptoms. The affected states include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
The recall, initiated by ByHeart, comes amid an ongoing investigation by the FDA, Centers for Disease Control and Prevention (CDC), and state health departments. Although no deaths have been reported, the FDA advises parents and caregivers to discard the formula from the identified lots. Symptoms of infant botulism, such as constipation, poor feeding, and difficulty swallowing, can take weeks to appear after ingestion.
ByHeart, based in New York City, stated that the recall is a precautionary measure to ensure infant safety. The company emphasized that neither its tests nor those conducted by regulatory agencies have confirmed the presence of Clostridium botulinum spores in the formula.
The California Department of Public Health has reported an increase in botulism cases among infants consuming ByHeart formula since August. Preliminary tests on a can of the formula suggest the presence of bacteria that produce botulinum toxin. The FDA is working with ByHeart to remove potentially impacted products from the market and is conducting further testing to identify the source of contamination.
Consumers are urged to monitor infants who have consumed the formula for any symptoms and to seek medical attention if necessary. For further assistance, ByHeart is providing a contact line and replacing affected products at no cost.
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