New Jersey-based Tris Pharma voluntarily recalled three lots of “Infants Ibuprofen Concentrated Oral Suspension USP (NSAID) 50 mg per 1.25 mL” in early December. The nationwide recall effects Walmart, CVS Pharmacy, and Family Dollar stores as some packages may contain high concentrations of ibuprofen.
No reports of adverse events have been received related to the recall, however, higher level of ibuprofen given to infants could result in permanent kidney damage, nausea, vomiting, stomach pain, diarrhea, tinnitus, headache, and gastrointestinal bleeding.
Specific ibuprofen recalls include:
The labels of the recalled products being sold at Walmart included expiration dates of February, April, and August 2019, while the CVS and Family Dollar products expire in August 2019.
In the U.S., ibuprofen’s use is largely confined to infants over six months of age due to safety concerns. Research has not shown a significant increase of adverse gastrointestinal or renal issues in infants younger than six months old compared to those over six months of age who have used the medication. There is, however, much less research on ibuprofen’s use in infants under six months.