FDA: 2 companies sold illegal infant products to hospitals

The Food and Drug Administration has warned two companies they say have been illegally selling probiotic products for infants that could be dangerous or even deadly.

One product in question is Similac Probiotic Tri-Blend made by Abbott Laboratories. The FDA said it is sold for use in hospital settings for preterm infants.

However, in a warning letter, the FDA said it reviewed Abbott’s website and marketing materials and found that Similac Probiotic Tri-Blend is an unapproved new drug and unlicensed biological product.

The letter indicates there is concern that there isn’t enough information about the ingredients to be sure the product won’t make preterm infants sick or cause other injuries.

Abbott has agreed to stop selling Similac Probiotic Tri-Blend and is working with the FDA to take additional corrective actions.

The second warning letter went to Infinant Health, Inc., formerly Evolve Biosystems, Inc., several weeks ago.

The FDA said their probiotic product, Evivo with MCT Oil, was given to an infant as part of in-hospital care. The child developed sepsis caused by a bacterium in the product and died.

A warning about this product was sent to healthcare providers in late September 2023.

Evivo with MCT Oil has since been voluntarily recalled and is no longer available in the United States.

The FDA says it has not approved any probiotic product for use as a drug or biological product in infants of any age.

Officials continue to investigate reports that probiotic products may have contributed to additional adverse events, including death.

On Thursday, Duke Hospitals, UNC Health and WakeMed each said they do not use either of the infant illegally sold probiotic products.