ByHeart said testing found the bacteria that can lead to botulism in cans of its infant formula, as US health officials identified additional babies who have been hospitalised with the illness.
Samples of the formula were examined by a third-party testing company based in Washington state, ByHeart said in a statement on its website. The number of babies who have been hospitalised since earlier this year with suspected or confirmed botulism linked to a recall of the formula swelled to 31 on Wednesday, according to US health officials.
ByHeart said it had immediately notified the Food and Drug Administration of the test results. "We are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again," it said.
The company recalled two lots of its formula on Nov. 8 and expanded the recall nationwide Nov. 11. But as the outbreak grows, state officials have reported finding cans of recalled ByHeart formula still on store shelves, the FDA said in an earlier statement.
"All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online," the FDA said. "This includes all formula cans and single-serve 'anywhere pack' sticks."
The agency also warned people outside the US who bought ByHeart formula online not to use it. The FDA's previous update was Nov. 14, when 23 babies were reported ill. The outbreak began as early as Aug. 9, and has expanded to 15 states from 13.
"We shouldn't tolerate this," FDA Commissioner Marty Makary said in a phone interview with Bloomberg, emphasizing that the agency has been moving "swiftly" to get a handle on the outbreak. "I'm not messing around when I say this, I don't want to see a single kid get sick" because of the pace of the recall.
ByHeart, which claims to make "closest to breast milk" formula with organic ingredients, became popular during a nationwide shortage in 2022. Still, it only accounts for about 1% of all US sales, the FDA has said.
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