Bromfenac Ophthalmic Solution 0.07%
Alembic Pharmaceuticals is recalling Bromfenac Ophthalmic Solution 0.07% (NDC 62332-583-03) due to failed impurities and degradation specifications.
Stop using this medication immediately. Contact your healthcare provider or pharmacist for a replacement prescription or alternative treatment.
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
How to identify it
Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic Pharmaceuticals Limited, Karakhadi- 391 450, Gujarat, India NDC 62332-583-03.
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification