Abbott to cease sale of infant probiotic products after FDA warning

(Reuters) -Abbott Laboratories has agreed to discontinue sales of its Similac Probiotic Tri-Blend product used for hospitalized preterm infants after the U.S. Food and Drug Administration issued a warning letter to the company.

FDA said it had sent warning letters to the company as it was concerned that preterm infants were at risk of potentially fatal diseases or infections, caused by bacteria or yeast contained in the probiotics. It had also sent a similar warning to Infinant Health. “The product is an unapproved new drug and an unlicensed biological product being sold in violation” of regulations, the health regulator said on Thursday about Abbott’s Similac.

Abbott did not immediately respond to a Reuters request for comment on the issue.

In 2023, an infant death was reported, and so far more than two dozen other adverse events associated with probiotic products have been reported in the United States since 2018, the agency said.

Certain probiotic products used in hospital settings to prevent a life-threatening bacterial illness have contributed to invasive diseases, the agency said.

The warning letter is different to the baby formula issue of last year, FDA said, referring to the closure of the company’s plant in Michigan following a recall of some products due to bacterial contamination.

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