ByHeart, the manufacturer of a widely used infant formula, announced today that laboratory testing has confirmed the presence of Clostridium botulinum bacteria in several recent production batches.
Public health officials have linked the contaminated formula to a cluster of severe gastrointestinal illnesses in infants across multiple states. More than a dozen babies have been hospitalized, exhibiting symptoms that range from vomiting and constipation to respiratory distress.
The U.S. Food and Drug Administration (FDA) has issued an immediate recall of the affected lots and is working closely with ByHeart to trace the source of the contamination. Consumers are urged to stop using the product and to return any unopened containers to the place of purchase for a full refund.
In a press release, ByHeart said, “We are deeply sorry for the distress this situation has caused families. Our top priority is the safety of the children who rely on our formula, and we are cooperating fully with health authorities to resolve the issue as quickly as possible.”
Parents who have purchased the recalled formula should:
Investigators are examining the manufacturing process to determine how the botulinum spores entered the supply chain. The Centers for Disease Control and Prevention (CDC) continues to monitor the situation and will provide updates as new information becomes available.