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# Tris Pharma Recalls 3 Infant Ibuprofen Lots
- URL: https://www.fdaweb.com/tris-pharma-recalls-3-infant-ibuprofen-lots/
- Published: 2019-01-30T12:00:00.000Z
- Updated: 2026-09-15T00:58:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143264

Tris Pharma has recalled three lots of infants’ ibuprofen concentrated oral suspension, 50 mg per 1.25 mL, because the products have been found to potentially have higher concentrations of ibuprofen. “There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury,” a [recall notice](https://www.fda.gov/Safety/Recalls/ucm627780.htm?utm%5Fcampaign=FDA%20MedWatch%20Recall%20Notice%20-%20Infants%E2%80%99%20Ibuprofen%20Concentrated%20Oral%20Suspension&utm%5Fmedium=email&utm%5Fsource=Eloqua) says. To date, Tris Pharma says it has not received any adverse event reports.