Tris Pharma Inc. issued a voluntary recall for three lots of liquid infant ibuprofen sold at Family Dollar, Walmart and CVS, the company announced on Thursday.
The New Jersey-based pharmaceutical company said its product labeled “Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL” might have a higher concentration of ibuprofen than advertised.
There’s a “remote possibility” that the drug could cause permanent kidney damage in infants, the company warned.
The drugs are sold under the names Family Wellness, Equate, and CVS Health, according to the company.
Possible adverse effects include nausea, vomiting, epigastric pain, diarrhea, tinnitus, headache and gastrointestinal bleeding. The company has not received any reports of adverse reactions to the recalled drug. Children with signs of adverse reactions should see a health care specialist.
Anyone with questions about the product can call Tris Customer Service at 732-940-0358 or email email@example.com.
Adverse reactions may be reported to the FDA’s MedWatch Adverse Event Reporting program.