Home / Recalls / Alembic Pharmaceuticals Limited / D-0447-2025

D-0447-2025 Class II Ongoing

Recalled by Alembic Pharmaceuticals Limited — Panchmahal, N/A

Recall Details

Product Type
Drugs
Report Date
June 4, 2025
Initiation Date
May 7, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

US Nationwide

Code Information

Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025

Other recalls by Alembic Pharmaceuticals Limited

  • D-0248-2026 Class III — Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manu (December 16, 2025)
  • D-0156-2026 Class III — Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, (October 10, 2025)
  • D-0566-2025 Class II — Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured (July 25, 2025)
  • D-0459-2025 Class II — Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic (May 9, 2025)
  • D-0326-2021 Class I — Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alem (March 17, 2021)
  • D-1341-2020 Class II — Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by (June 10, 2020)