The Recall Desk
ModerateFDA (Drugs)·D-0447-2025·Announced 2025-06-04

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.

What this means for you

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
Hazard
  • impurities
  • degradation
  • specification-failure

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.

Related recalls

Same category