FDA Recall D-0447-2025

Alembic Pharmaceuticals Limited · Panchmahal, N/A

Class II Ongoing 372 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

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

Quantity: N/A

Reason for recall

Failed Impurities/Degradation Specifications

Recall record

Recall number: D-0447-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide
Recall initiated: 2025-05-07
Classified by FDA Center: 2025-05-27
FDA published: 2025-06-04
Recalling firm: Alembic Pharmaceuticals Limited
Firm location: Panchmahal, N/A, India

Drug identification

Brand name(s): BROMFENAC OPHTHALMIC SOLUTION 0.09%
Generic name(s): BROMFENAC OPHTHALMIC SOLUTION 0.09%
Manufacturer(s): Alembic Pharmaceuticals Inc.
NDC(s): 62332-508
Route(s): OPHTHALMIC

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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