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Abbott Recalls Similac Probiotics Products After FDA Warning

Abbott Laboratories has recalled its Similac Probiotic Tri-Blend baby food product after the FDA warns parents and healthcare providers against using probiotics to treat diseases in preterm babies.
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By Wyndi Kappes, Associate Editor
Updated November 9, 2023
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Image: Iryna Inshyna | Shutterstock

All parents want their baby to get the best start possible, and for parents whose children are born premature, there can be even more pressure to help build your child a strong foundation. While probiotics may seem like a sure-fire way to shore up your little one’s gut health, the Food and Drug Administration (FDA) has warned parents and healthcare providers that probiotics could prove more harmful than helpful.

On October 26, the FDA released its warning, raising concerns about the use of probiotics primarily in preterm infants. The warning was spurned by the death of a child earlier this year and at least two dozen other reports of adverse effects to probiotic usage since 2018.

“Products containing live bacteria or yeast, which are commonly called probiotics, pose to preterm infants in hospital settings,” the FDA wrote. “The FDA is concerned as these products can be dangerous for preterm infants and are being illegally sold to treat or prevent diseases in preterm infants in hospital settings, such as to reduce the risk of necrotizing enterocolitis. Preterm infants who are administered a probiotic product are at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast contained in the probiotics.”

Not only did the organization condemn the use of probiotics in hospital settings, but it also clarified that it has not approved “any probiotic product for use as a drug or biological product in infants of any age,” and that any such products “ have not undergone the agency’s rigorous premarket process to evaluate their safety, effectiveness and quality for these medical uses.”

Prior to releasing this warning the FDA noted that it had issued warning letters to Abbott Laboratories for its product, Similac Probiotic Tri-Blend and Infinant Health, Inc for its probiotic product, Evivo with MCT Oil. Both products are unlicensed and unapproved and have been asked to be removed from the market. Both companies have agreed to stop production of the products and have issued voluntary recalls since. (Abbott Laboratories is recalling over 226,000 units of its Similac Probiotic Tri-Blend baby food, which come in cartons of 50 .017-oz packets and have a lot number of 45002IP, product number of 67397 and expiration date of September 1, 2024, according to Food Safety News.)

The American Academy of Pediatrics (AAP) does not recommend the use of probiotics in preterm infants, although it estimates that 10 percent of preterm infants receive a probiotic during their stay in the neonatal intensive care unit (NICU). The FDA encourages parents to talk with their doctor about their child’s care if they have any concerns.

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