The company says that as of Wednesday it has not received any reports of adverse events related to the lots of product being recalled.
Several lots of infant liquid ibuprofen are being recalled due to the bottles potentially containing higher concentrations of ibuprofen.
Side effects are nausea, vomiting, epigastric pain, or more rarely, diarrhea.
The affected products contain expiration dates of February, April or August 2019 at Walmart and August 2019 at CVS and Family Dollar.
There's a "remote possibility" that the drug could cause permanent kidney damage in infants, the company warned. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.
The recalled lots from Walmart are 00717009A, 00717015, and 00717024A.
The Monmouth Junction, New Jersey-based drug maker said it sold the affected lots "to one customer, which distributed the lots into the US market".
Consumers concerned about a product they may have recently purchased can call Tris Pharma's customer service number at 732-940-0358.
According to the label, the ibuprofen - meant to be used as a pain reliever or fever reducer - contained 50 mg per 1.25 mL.
They were sold at Family Dollar, Walmart and CVS.
"This recall is being conducted with the knowledge of the U.S. Food and Drug Administration".