Copyright The New York Times
ByHeart, a maker of organic baby formula, expanded a voluntarily recall on Tuesday to include all of its products sold nationwide after federal health regulators found botulism infections in two additional infants, bringing the number of reported cases to 15. The expanded recall was announced days after the Food and Drug Administration told caregivers to stop using two batches of ByHeart’s powdered Whole Nutrition Infant Formula after health agencies found an increase in the number of botulism infections in infants who had consumed it. The F.D.A. said on Saturday that 13 infants had been hospitalized in 10 states. On Tuesday, the agency asked ByHeart to expand the recall to include all of its powdered formula after the number of hospitalized infants rose to 15 in 12 states. The infants, who are between the ages of 16 days and a little over 5 months, became ill between Aug. 9 and Monday, 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. No deaths have been reported. The F.D.A. said the 15 cases of botulism had been found in infants in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. Parents and caregivers should immediately stop using the recalled formula, the C.D.C. said. Anyone who has fed the formula to an infant should keep the container for 30 days and monitor the child for signs of botulism, the agency said. If a child develops symptoms, state health regulators may want to collect the formula for testing. It can take several weeks for symptoms of infant botulism to appear. Symptoms of botulism, which can be fatal, include poor feeding, loss of head control, difficulty swallowing and decreased facial expression. “We are so sorry for the immense anxiety and fear that we have been causing you these past few days,” Mia Funt and Ron Belldegrun, the founders of ByHeart, wrote in a statement announcing the expanded recall that was posted on the company’s website on Tuesday. “Upon learning about this outbreak on Friday evening, we immediately began conducting our own extensive testing on all ByHeart batches,” they added. “Additionally, we are providing the F.D.A. complete and unrestricted access to all of our facilities and products for their investigation, which has been done regularly at our owned facilities. We will share the results of our own testing as they become available.” The F.D.A. estimated that ByHeart products represent less than 1 percent of all infant formula sold in the United States and said that the outbreak should not lead to a formula shortage.
