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 dangerous, according to the recall announcement.
The over-the-counter liquid pain reliever and fever reducer is meant for infants who are between the ages of 6 months and 23 months old. Adverse events from the medication may include nausea, vomiting, upper abdominal pain, diarrhea, gastrointestinal pain, ringing in the ears and headache, although no adverse events related to the recalled ibuprofen have been reported, according to Tris Pharma.
"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.
The recalled medications were 0.5 ounce bottles sold nationwide at CVS, Family Dollar and Walmart stores.
The Equate ibuprofen packages sold at Walmart have an national drug code of 49035-125-23 and include lot numbers 00717009A with an expiration date of February 2019, 00717015A with an expiration date of April 2019 and 00717024A with an expiration date of August 2019.
The CVS ibuprofen packages have a national drug code of 59779-925-23 and include lot number 00717024A with an expiration date of August 2019.
The ibuprofen sold at Family Dollar and branded as Family Wellness has a national drug code of 55319-250-23 and include lot number 00717024A with an expiration date of August 2019.
Consumers who have this medication should return it or throw it away. It should not be used. Retailers should discontinue selling it.