FDA Drug Recalls

Recalls / Active ingredient / Bromfenac Sodium

Bromfenac Sodium

3 FDA drug recalls involving the active ingredient “Bromfenac Sodium.

DateClassProductFirm
2025-05-07Class IIBromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic PharmaceuticalAlembic Pharmaceuticals Limited
2021-03-15Class IIBROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPSCardinal Health Inc.
2019-01-24Class IIBromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical InSun Pharmaceutical Industries, Inc.