Outbreak expands as more babies are hospitalized

Infant botulism cases in the United States continue to climb, with 31 babies now hospitalized since early this year in connection with contaminated ByHeart infant formula. The company confirmed that third-party testing detected bacteria capable of causing botulism in its product, prompting a series of recalls.

ByHeart, which promotes its formula as being “closest to breast milk” and made with organic ingredients, said it alerted the US Food and Drug Administration immediately after receiving the test results.

Recalled formula still found in stores

Although ByHeart recalled two lots of its formula on November 8 and expanded the recall nationwide on November 11, state officials are still discovering recalled cans on retail shelves. The FDA criticized the continued availability of the product, stressing that no ByHeart formula should be sold in stores or online.

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The warning extends to consumers outside the United States who may have purchased the formula digitally.

FDA vows strong response

FDA Commissioner Marty Makary said the agency is taking decisive action to control the outbreak and prevent further illnesses. He emphasized the urgency of removing the product from circulation, underscoring that even a single additional case is unacceptable.

The outbreak, which began on August 9, has now spread to 15 states, up from 13 in the agency’s previous update on November 14, when 23 babies were reported ill.

The company became popular during the 2022 formula shortage

ByHeart gained significant traction in 2022 amid a nationwide formula shortage, although it still represents only about 1% of total US infant formula sales, the FDA noted. The company said it is continuing its investigation to determine how the contamination occurred and to prevent future incidents.