The company is warning that there is a possibility that infants may be more vulnerable to permanent NSAID-associated kidney injury because they are more susceptible to a higher potency level of the drug. Other adverse effects may include nausea, vomiting, pain below the ribs in the upper abdomen and diarrhea.
Tris Pharma said, to date, it hasn't received any reports of adverse events related to the recall. "Tinnitus, headache and gastrointestinal bleeding".
Ibuprofen belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).
Tris Pharma said the product was used as a pain reliever or fever reducer, and was packaged in 0.5 ounce bottles.
It's sold under the "Family Wellness" label with the NCD 55319-250-23 and lot number 00717024A by Family Dollar.
At CVS, the recalled lot is 00717024A (expires 08/19).
The affected products contain expiration dates of February, April or August 2019 at Walmart and August 2019 at CVS and Family Dollar. The company said it sent the ibuprofen to one distributor and has contacted them to let them know about the announcement.
If you have experienced any problems from using the medication, contact your doctor or healthcare provider.