Bromfenac Ophthalmic Solution 0.09% recall
FDA recall D-0447-2025 · initiated May 7, 2025
Alembic Pharmaceuticals Limited recalled Bromfenac Ophthalmic Solution 0.09% in May 2025 — an FDA Class II recall (D-0447-2025) because Failed Impurities/Degradation Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- 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
- Recalling company
- Alembic Pharms Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide
- Initiated
- May 7, 2025
- FDA report date
- Jun 4, 2025
Frequently asked
- Was Bromfenac Ophthalmic Solution 0.09% recalled?
- Alembic Pharmaceuticals Limited recalled Bromfenac Ophthalmic Solution 0.09% in May 2025 — an FDA Class II recall (D-0447-2025) because Failed Impurities/Degradation Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Bromfenac Ophthalmic Solution 0.09% recalled?
- Per the FDA enforcement record, the reason for recall D-0447-2025 was: Failed Impurities/Degradation Specifications
- Is a recalled Bromfenac Ophthalmic Solution 0.09% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Bromfenac Ophthalmic Solution 0.09% are affected?
- Distributed: US Nationwide. The recall covers these lots — Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0447-2025.