A recall of infant ibuprofen has been expanded to include three more lots that could
have high concentrations of the drug.
Tris Pharma Inc. has voluntarily recalled six lots of Infants’ Ibuprofen Concentrated
Oral Suspension, USP (NSAID) 50 milligrams per 1.25 milliliters since December 2018.
The medication was sold in 0.5 ounce and 1-ounce bottles to reduce fever and pain
under the Equate, CVS Health and Family Wellness brands at Walmart, CVS and Family
Dollar stores, respectively. Additional details on lot numbers and expiration dates
are available at https://www.fda.gov/Safety/Recalls/ucm630112.htm.
No adverse events have been reported to Tris Pharma Inc., but ibuprofen concentrations
have been found as high as 10% above the specified limit, according to the company.
The higher potency could cause nausea, vomiting, diarrhea, tinnitus, headache and
gastrointestinal bleeding, according to the company. Infants may be more vulnerable
to permanent kidney damage.