CLASS II ONGOING Drug recall · Reported 4 Jun 2025 · FDA Enforcement Report
Bromfenac Ophthalmic Solution recalled by Alembic Pharmaceuticals
Alembic Pharmaceuticals is recalling Bromfenac Ophthalmic Solution 0.09%, distributed nationwide in the US. The recall was initiated on 7 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0447-2025
- FDA event ID
- 96836
- Recalling firm
- Alembic Pharmaceuticals, Panchmahal, N/A
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 May 2025
- FDA classified
- 27 May 2025
- Reported
- 4 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 7 May 2025 | Recall initiated by company | |
| 27 May 2025 | Classified by FDA | +20 days |
| 4 Jun 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Alembic Pharmaceuticals
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 8 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 4 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxepin Hydrochloride Capsules, USP, 10 mg recalledDoxepin Hydrochloride | Alembic Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Celecoxib Capsules, 200 mg recalled by Alembic PharmaceuticalsCelecoxib | Alembic Pharmaceuticals | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS III | Tobramycin Opthalmic Solution recalled by Alembic PharmaceuticalsTobramycin Ophthalmic Solution | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
Other Bromfenac recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Cardinal HealthBromfenac Ophthalmic Solution 0.09% | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | BromSite (bromfenac ophthalmic solution) recalledBromsite | Sun Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution 0.09%, a) bottles recalled | Mayne Pharma Usa | Sterility | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Apotex | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Bausch & Lomb | Bausch & Lomb | Sterility | Nationwide |