Infant Formula Recall Issued Over Rising Botulism Cases Linked to ByHeart Whole Nutrition

Health authorities have issued an urgent advisory urging parents and caregivers to discard two specific lots of ByHeart Whole Nutrition infant formula after the product was implicated in a cluster of infant botulism cases across several states. The U.S. Food and Drug Administration (FDA), in coordination with the Centers for Disease Control and Prevention (CDC) and state health departments, announced the recall on Tuesday, citing preliminary laboratory evidence that the formula may have been contaminated with *Clostridium botulinum* spores.The recall targets lot numbers 2023‑07‑01 and 2023‑07‑02, both produced at ByHeart’s manufacturing facility in Pennsylvania and distributed nationwide between mid‑June and early July. According to the FDA, at least six infants have been diagnosed with botulism symptoms—including constipation, weak cry, poor feeding, and, in two cases, respiratory distress—after consuming the recalled formula. All affected children are currently receiving medical care, and none have been reported to have suffered permanent neurological damage.“This is a rare but serious condition, and the rapid identification of a potential source is critical to preventing further illness,” said Dr. Rochelle Walensky, director of the CDC, during a press briefing. “We are working closely with ByHeart and the FDA to ensure that any contaminated product is removed from the market and that families receive clear guidance on next steps.”ByHeart, a rapidly growing company that markets its formula as “whole‑food” nutrition for infants, released a statement expressing deep regret over the situation. “The safety of the babies who rely on our products is our top priority,” the statement read. “We are cooperating fully with federal investigators, have halted distribution of the implicated batches, and are conducting a thorough internal review of our manufacturing and quality‑control processes.”The FDA’s investigation is still ongoing, but officials indicated that preliminary testing of unopened containers from the two recalled lots detected trace amounts of botulinum toxin genes, a finding that prompted the immediate recall. The agency has also instructed healthcare providers to remain vigilant for signs of infant botulism and to report any suspected cases to the CDC’s Botulism Surveillance System.Parents who have purchased ByHeart Whole Nutrition formula are advised to check the lot number printed on the packaging—located on the side of the can or pouch—and to stop using the product immediately if it matches either of the recalled numbers. The FDA recommends returning the product to the place of purchase for a full refund, or contacting ByHeart’s consumer hotline at 1‑800‑555‑0123 for disposal instructions. Families who suspect their child may have been exposed should seek medical attention promptly, especially if the infant shows signs such as constipation lasting more than three days, lethargy, or difficulty feeding.This recall follows a series of heightened concerns about infant formula safety in the United States, which has seen periodic shortages and quality‑control scandals in recent years. Public health experts say the incident underscores the importance of rigorous testing and transparent supply‑chain practices, particularly for products intended for the most vulnerable populations.The FDA and CDC will continue to monitor the situation and provide updates as more information becomes available. In the meantime, they urge caregivers to stay informed, follow the recall instructions, and consult pediatricians for alternative feeding options if needed.