The three recalled lots of Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL may have concentrations of ibuprofen that are too high and therefore could be unsafe, according to the recall announcement.
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.
A company statement read there is also a "remote possibility" that infants may experience side effects including nausea, vomiting, stomach pain and diarrhea due to the increased potency.
The recalled lots from Walmart are 00717009A, 00717015, and 00717024A.
The affected products contain expiration dates of February, April or August 2019 at Walmart and August 2019 at CVS and Family Dollar. At CVS, the recalled lot is 00717024A (expiry 08/19).
A New Jersey pharmaceutical manufacturer is recalling some infants' Ibuprofen sold at Walmart, CVS and Family Dollar Stores over concerns that the medicine may be too potent.
Eastern TIme to 5:00 p.m.
Contact your healthcare provider if your baby has experienced any problems that may be related to using this product.
"This recall is being conducted with the knowledge of the U.S. Food and Drug Administration".