Tris Pharma, Inc., a New Jersey based pharmaceutical manufacturer, has issued a voluntary recall of infant ibuprofen that may contain higher concentrations than noted on the bottle, leading to potential risks in infants. The impacted lots of medication were sold to a distributor that supplies retailers, including CVS, Walmart, and Family Dollar. Retailers and wholesalers of the product have been instructed to discontinue distribution of the affected medication.

In their recall notice, the company referred to a “remote possibility” that the increased about of ibuprofen contained in the .5oz bottles could lead to permanent kidney injury in infants. Other negative effects could include nausea, vomiting, diarrhea, tinnitus, headaches, and possible stomach bleeding. As of today, the company has not received any reports of adverse events related to the recall.

The recalled product, a pain reliever and fever reducer, was sold in .5oz bottles and labeled “Infants’ Ibuprofen Concentrated Oral Suspension.” The product is sold at Walmart under the “Equate” label, at CVS under the “CVS Health” label, and at Family Dollar under their “Family Wellness” label.

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