Copyright Newsweek
ByHeart Inc. is expanding a voluntary recall announced earlier this month amid an ongoing investigation from the U.S. Food and Drug Administration (FDA) into a recent outbreak of infant botulism. When reached for comment on Tuesday, ByHeart Inc. sent Newsweek the company's press release and letter from the co-founders. Why It Matters Numerous public health alerts and recalls have been issued this year due to the potential for damaged products, foodborne illness, contamination and undeclared food allergens. Millions of Americans experience food sensitivities or allergies every year. According to the FDA, the nine "major" food allergens in the United States are eggs, milk, fish, wheat, soybeans, crustacean shellfish, sesame, tree nuts and peanuts. "Infant botulism is a rare but serious illness that occurs when Clostridium botulinum spores are ingested and then colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants," the alert says in part. What To Know ByHeart Inc. announced on Tuesday that it has expanded its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide. The cans' UPC number is 85004496800, and the Anywhere Packs' number is 85004496802. This action follows reports of 15 suspected or confirmed cases of infant botulism across 12 states as of Monday, all requiring hospitalization, though no deaths have been reported, the FDA says. The FDA, U.S. Centers for Disease Control and Prevention (CDC), and the California Department of Public Health (CDPH) are conducting a comprehensive investigation. Although no unopened can of ByHeart formula has tested positive for Clostridium botulinum spores or toxins, authorities have identified a number of botulism cases involving infants who consumed ByHeart formula. The alert notes that ByHeart is testing every batch of formula "with an independent third-party laboratory," and allowing the FDA and CDPH access to their facilities and unopened cans for testing "without restriction." What People Are Saying ByHeart co-founders Mia Funt and Ron Belldegrun said in a letter on the company's website: "The decision to broaden our recall to all ByHeart products comes after a call with the FDA late last night, informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point. The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions. Your baby’s safety is, and always will be, our biggest priority." What Happens Next People who have purchased the recalled formula are urged to "immediately discontinue use" and throw the product away. Parents with additional questions may contact the company via email at hello@byheart.com to speak with experts, the alert says.
