Preliminary testing has detected the bacteria responsible for producing the botulism toxin in ByHeart baby formula, California health officials said, following an outbreak that has sickened at least 13 infants in 10 U.S. states since mid-August. No deaths have been reported so far.
“Consumers in possession of this product should stop using it immediately,” the California Department of Public Health warned in a statement late Saturday.
The ongoing investigation by state and federal health agencies involves additional testing of ByHeart’s Whole Nutrition Infant Formula. The New York-based company has recalled two lots of the powdered formula, which carry a best-by date of December 2026.
The U.S. Centers for Disease Control and Prevention (CDC) said affected infants, aged between two weeks and five months, were hospitalized after consuming the formula. Reported cases have occurred in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
California health authorities tested a can of ByHeart formula that had been fed to an infected baby. Early results “suggest the presence” of the bacteria linked to botulism, though confirmatory testing could take several days.
ByHeart said in a statement that further testing is required to determine if the bacteria that causes botulism are indeed present, noting that many related bacteria occur naturally and are not harmful. “We take this very seriously,” the company said Sunday.
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The U.S. Food and Drug Administration (FDA) is investigating a total of 83 reports of infant botulism since August, including those connected to ByHeart.
Botulism, though rare, affects fewer than 200 U.S. infants annually. It is caused by bacteria that produce toxins in the large intestine, potentially leading to paralysis. Infants under one year are most at risk, with symptoms including weak muscle tone, drooping eyelids, poor feeding, and breathing difficulties.
All infants affected in the ByHeart-linked outbreak have been treated with BabyBIG, the only available treatment for infant botulism. Produced by California’s Infant Botulism Treatment and Prevention Program, BabyBIG is made from plasma of immunized adults and helps shorten hospital stays.
Officials said the outbreak poses no risk to national formula supplies, as ByHeart represents just 1% of U.S. formula sales. The company previously recalled five batches in 2022 after detecting a different bacterium, cronobacter sakazakii, at its packaging facility — the same germ at the center of the 2022 Abbott Nutrition crisis that caused a nationwide shortage.
Meanwhile, the FDA, under the direction of Health Secretary Robert F. Kennedy Jr., is reviewing infant formula ingredients and nutrient standards under a new initiative called “Operation Stork Speed” — the first comprehensive review since 1998.
Source: AP