Copyright The New York Times
The Food and Drug Administration said on Saturday that parents and caregivers should stop using some batches of ByHeart Whole Nutrition Infant Formula after health agencies found an increase in the number of botulism infections in infants who had consumed the powdered formula. Since August, at least 13 infants in 10 states who had been given the formula have had botulism type A infections, according to the F.D.A., which is investigating the outbreak with the Centers for Disease Control and Prevention and state and local health agencies, including California’s Infant Botulism Treatment and Prevention Program. No deaths have been reported. In a statement about the outbreak, the F.D.A. identified two lots of the infant formula, which is available online and at major retailers, that it said should not be used: 206VABP/251261P2 and 206VABP/251131P2. The product is being tested, the agency said, and the results should be available in the next few weeks. Caregivers of children who have consumed the formula and who are displaying signs of botulism should immediately seek medical care. Symptoms of botulism, which can be fatal, include poor feeding, loss of head control, difficulty swallowing and decreased facial expression. It can take several weeks after the formula is consumed before symptoms appear, according to the F.D.A. The agency estimated that the formula represented less than 1 percent of all infant formula sold in the United States and said that the outbreak should not lead to formula shortages. In 2022, infant formula had to be airlifted from Europe because of a nationwide shortage that was driven by the closure of a production plant over contamination concerns and lingering supply chain issues related to the coronavirus pandemic. ByHeart, the maker of the formula identified by the F.D.A., said in a statement that it had initiated a voluntary recall of the two batches of its product. The company said the F.D.A. on Friday told it that an estimated 83 cases of infant botulism had been reported since August and of those cases, 13 infections were in infants who had been given the ByHeart formula. The source of the other infections was unknown. Mia Funt, a founder and the president of ByHeart, said in the statement that the recall was done out of an “abundance of caution.” “We take any potential safety concern extremely seriously, and act quickly to protect families,” Ms. Funt said. “As parents ourselves, we understand the concern this news may raise.” Ms. Funt said ByHeart and regulatory agencies had not confirmed the presence of botulism spores or toxins in its products, but the recall was in place “to remove any potential risk from the market and ensure the highest level of safety for infants.” The F.D.A. said the 13 cases of botulism were found in infants in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
