FDA Drug recall D-0447-2025
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921…
- FDA Drug
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921… by Alembic Pharmaceuticals, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0447-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-07 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alembic Pharmaceuticals |
| Distribution | US |
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
Reason
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 62332-508-17 |
|---|---|
| code_info | Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class III · 2025-11-26 · Alembic Pharmaceuticals - Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujar…
FDA Drug · Class II · 2025-08-13 · Alembic Pharmaceuticals - Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389…
FDA Drug · Class II · 2025-06-18 · Alembic Pharmaceuticals - Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 623…
FDA Drug · Class III · 2023-08-23 · Alembic Pharmaceuticals
All Alembic Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0447-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.