United StatesBromfenac Ophthalmic Solution 0.07%, 3 mL (Rx only), NDC 62332-583-03, manufactured for Alembic Pharmaceuticals, lot numbers 7240184, 7240185, 7240186, 7240187 (exp. 3/31/2026) and lot 7240278 (exp. 5/31/2026), sold nationwide in the USA, is affected. The product was recalled because samples were out of specification for impurities/degradation during 20‑month stability testing.
What's being recalled
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.
Recalling firm: Alembic Pharmaceuticals, Inc., Bedminster, NJ, United States.
How to identify it
Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026.
The hazard
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)