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.
FDA recall notice · announced April 8, 2026 · Alembic Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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.
Reason for recall
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026.
Status: Ongoing
Products in this recall event:
- 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
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.