In a statement, the company said there is a "remote possibility" that the higher potency of the drug can lead to permanent kidney damage in infants.
Adverse effects include nausea, vomiting and stomach bleeding. However, Tris Pharma said it has not received any reports of injuries or illness from the recalled products.
Ibuprofen belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).
The recall affects bottles with national drug codes 49035-125-23, 59779-925-23 and 55319-250-23. The recalled lots are sold in Walmart, CVS and Family Dollar.
Tris Pharma announced the recall on Thursday involving CVS store brand, Equate brand sold at Walmart and Family Wellness brand sold at Family Dollar.
CVS Pharmacy: The expiration date includes 08/19. Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product.
The drug maker said the recalled lots were sold to a customer who distributes them to retailers, but it's unknown which states are affected.
If you have experienced any problems from using the medication, contact your doctor or healthcare provider.
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