Tris Pharma has expanded its voluntary recall of infant ibuprofen because it may contain overly high concentrations of the drug.
The company, based in Monmouth Junction, New Jersey, announced the move this week.
It says the concentration can be as high as 10 percent above the specified limit. The affected brands include CVS Health and Equate and are sold at Walmart, CVS and Family Dollar stores.
Infants already susceptible to the adverse effects of ibuprofen could be at a slightly higher risk if given medication from a recalled bottle. There’s a remote possibility an elevated level of ibuprofen could lead to permanent kidney damage in babies.
Other potential adverse health effects include nausea, vomiting, stomach pain and diarrhea.
Tris Pharma says it hasn’t received any reports of related health problems.