ByHeart Recalls Infant Formula Amid Multistate Botulism Investigation

ByHeart has initiated a voluntary recall of two lots of its Whole Nutrition Infant Formula after 13 cases of infant botulism were reported across 10 states. The affected lot numbers are 206VABP/251261P2 and 206VABP/251131P2, both with a "Use by" date of December 1, 2026. 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 hospitalizations but no reported deaths.

The cases have been identified in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. Infant botulism is a rare but serious illness caused by a toxin produced by Clostridium botulinum bacteria. Symptoms can include constipation, poor feeding, loss of head control, and difficulty swallowing, potentially progressing to paralysis and respiratory failure.

ByHeart stated that the recall is a precautionary measure, emphasizing that no testing has confirmed the presence of Clostridium botulinum in their products. The company is collaborating with the FDA to ensure all potentially impacted products are removed from the market.

Parents and caregivers are advised to check the lot numbers on the bottom of the formula cans and discontinue use of the recalled products. The FDA recommends recording the lot number before disposing of the product and cleaning any surfaces that may have come into contact with the formula. If an infant exhibits symptoms of botulism, immediate medical attention is crucial.

ByHeart's Whole Nutrition Infant Formula accounts for approximately 1% of the U.S. infant formula market and is available online and at major retailers nationwide. The FDA and CDC continue to investigate the source of contamination and are working to determine if additional products are affected.