FDA announces recall of infant’s medication due to potential for higher concentrations of ibuprofen

Posted at 2:45 PM, Dec 09, 2018
and last updated 2018-12-09 16:45:21-05

(KSTU) — The Food and Drug Administration announced a voluntary recall Wednesday of three types of infant’s Ibuprofen after it was found that the products potentially have a higher concentration of Ibuprofen, which may result in renal injury to younger children.

All of the brands of Ibuprofen were 50 mg per 1.25 ml, the FDA said.

Equate: Infants’ Ibuprofen Concentrated Oral Suspension, sold at Walmart, CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension and Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, sold at Family Dollar, were all part of the recall.

The FDA wrote in a press release that, “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.”

All of the products were produced by Tri Pharma Inc., the FDA said. The company sold the medication to one customer, who in turn distributed the medication to the above stores in the U.S. market.

For more information on the recall, click here.

Images of the recalled products can be seen below, courtesy FDA: