The release added there is a slight possibility that a higher potency could cause infants to develop permanent renal or kidney injuries.
Adverse effects can include nausea, vomiting, epigastric pain, diarrhea, tinnitus, headache and gastrointestinal bleeding, the company said.
However, Tris Pharma said in the news release that it has not received any reports of adverse reactions to the medication covered in the recall.
Recalled infants' Ibuprofen sold at Walmart, CVS, Family Dollar
The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles.
The Monmouth Junction, New Jersey-based drug maker said it sold the affected lots "to one customer, which distributed the lots into the USA market".
Any consumers with questions or concerns are urged to contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8 a.m. ET- 5 p.m. PT) or via email at firstname.lastname@example.org.
The product was sold in Walmart under the "Equate" brand, in CVS under the "CVS Health" brand and in Family Dollar under the "Family Wellness" label.