After USFDA warning, Abbott Labs to stop sales of Similac Probiotic Tri-Blend product

Infinant's product, sold under the brand Evivo with MCT Oil, has since been voluntarily recalled and is no longer available in the country, the FDA said.

Infinant did not immediately respond to a Reuters request for comment.

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 U.S. since 2018, the agency said.

The FDA is also investigating reports that these products may have contributed to additional adverse events, including death, and is working to obtain the evidence and medical records.

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 Abbott's plant in Michigan following a recall of some products due to bacterial contamination.