FDA Taking Action Against Unapproved Prescription Ear Drops

FDA is taking action against 16 prescription drugs labeled to relieve ear pain and swelling because they are unapproved and haven’t been evaluated by FDA for safety, effectiveness and quality. Parents and other consumers still will have many other options for treating ear pain.

These ear drops contain active ingredients such as benzocaine and hydrocortisone but have not been evaluated by FDA for safety, effectiveness and quality.

The quality of these drugs is uncertain. When FDA approves a drug, we review the manufacturing processes to ensure that the drugs are of consistent quality and purity, Lee says. That’s not the case with these unapproved ear drops. Read