Bromfenac Ophthalmic Solution 0 — Class II drug recall D-0447-2025
Ongoing recall by Alembic Pharmaceuticals Limited, reported 2025-06-04, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0447-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alembic Pharmaceuticals Limited, Panchmahal, N/A, India |
| Recall initiated | 2025-05-07 |
| Classified | 2025-05-27 |
| Reported by FDA | 2025-06-04 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 62332-0508, 62332-0508-17 |
| Lot numbers | 7230309, 7230310, 7230311 |
| Expiration dates | 2025-05-31 |
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 for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0447-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.