Bromfenac Ophthalmic Solution 0.09% recalls
Bromfenac Ophthalmic Solution 0.09% products have been recalled 2 times, most recently on 4 Jun 2025. The recalling company is usually Cardinal Health. The most common reason is sterility.
Total recalls2since 2021
Last 12 months0reported
Class I00% of total
Ongoing1latest 4 Jun 2025
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why bromfenac ophthalmic solution 0.09% is recalled
Companies
Product types
By year
Ongoing bromfenac ophthalmic solution 0.09% recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09% | Alembic Pharmaceuticals | Sterility | Nationwide |
All bromfenac ophthalmic solution 0.09% recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09% | Alembic Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Cardinal HealthBromfenac Ophthalmic Solution 0.09% | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.