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# Tris Pharma Recalls Infant Ibuprofen
- URL: https://www.fdaweb.com/tris-pharma-recalls-infant-ibuprofen/
- Published: 2018-12-06T12:00:00.000Z
- Updated: 2026-09-15T00:49:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142983

Tris Pharma has recalled three lots of infant ibuprofen concentrated oral suspension (50 mg per 1.25 mL) due to the potential for the product higher concentrations of ibuprofen than labeled. There is a remote possibility that infants, who may be more susceptible to higher drug potency levels, may be more vulnerable to permanent NSAID-associated renal injury, a [recall notice ](https://www.fda.gov/Safety/Recalls/ucm627780.htm?ref=fdaweb.com)says. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. To date, Tris Pharma has not received any related adverse event reports.