According to the manufacturer, Tris Pharma, the recalled products "have been found to potentially have higher concentrations of ibuprofen".
The recalled drugs were packaged in 0.5 oz. bottles and labeled "Infants" Ibuprofen Concentrated Oral Suspension'.
"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", the recall announcement said. Other possible adverse effects include tinnitus (ringing in the ears), headaches and stomach bleeding.
The affected products were sold at several Walmart, CVS Pharmacy and Family Dollar stores across the country.
The recalled lots from Walmart are 00717009A, 00717015, and 00717024A.
So far the recall does not say which states received the product.
Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00 a.m. ET- 5:00 p.m. PT) or via email at mailto:email@example.com.
If you have experienced any problems from using the medication, contact your doctor or healthcare provider.
The company said that the recall is being conducted with the knowledge of the U.S. Food and Drug Administration.