A nationwide recall has been issued for ByHeart Whole Nutrition Infant Formula following reports of infant botulism in at least 15 babies across a dozen states, including Pennsylvania. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are investigating the outbreak, which has led to the hospitalization of all affected infants.
ByHeart, a New York-based company with a manufacturing facility in Exeter Township, Pennsylvania, voluntarily recalled two batches of its formula after being notified by the FDA of the ongoing investigation. The specific batches involved are 206VABP/251261P2 and 206VABP/251131P2. According to the FDA, there is no direct link between the formula and the botulism cases, and no ByHeart product has tested positive for contamination. However, the recall is a precautionary measure to ensure infant safety.
The CDC advises parents to check the batch numbers on the bottom of the cans and discard any formula from the affected batches. Parents should also clean any surfaces that came into contact with the formula and seek medical attention if their infant shows symptoms of botulism, such as poor feeding or difficulty swallowing.
The CDC and FDA continue to investigate the source of contamination, with testing of leftover formula underway. The recall affects about 1% of national formula sales, and no deaths have been reported. ByHeart emphasizes its commitment to safety and transparency, stating, "The safety and well-being of every infant who uses our formula is our absolute highest priority."