Bromfenac Ophthalmic Solution 0.09% Recalled for Failed Impurities Specifications
Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% nationwide due to failed impurities and degradation specifications. Three affected lots expire May 31, 2025.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing quality defect (failed specifications) without confirmed evidence of patient harm.
Plain-English summary
Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% (prescription eye drops) distributed nationwide because the product failed to meet impurities and degradation specifications.
The affected lots are: Lot 7230309 (Exp. 5/31/2025), Lot 7230310 (Exp. 5/31/2025), and Lot 7230311 (Exp. 5/31/2025). The product is supplied in 1.7 mL bottles, NDC 62332-508-17, manufactured in India.
Patients currently using this medication should contact their healthcare provider or pharmacist before discontinuing use. Healthcare providers may consider alternative treatments if needed. Do not use recalled product.
The recalled product
- Product
- BROMFENAC OPHTHALMIC SOLUTION 0.09% (BROMFENAC OPHTHALMIC SOLUTION 0.09%)
- Brand
- BROMFENAC OPHTHALMIC SOLUTION 0.09%
- Manufacturer
- Alembic Pharmaceuticals Limited
- Category
- Drug — Ophthalmic / Eye drops
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot 7230309
- Exp Date: 5/31/2025
- Lot 7230310
- Lot 7230311
Distribution
Distributed nationwide across the United States.
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