Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bromfenac Ophthalmic Solution 0.09% Recalled by Alembic Pharmaceuticals Limited Due to Failed Impurities/Degradation Specifications
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alembic Pharmaceuticals Limited directly.
Affected Products
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
Quantity: N/A
Why Was This Recalled?
Failed Impurities/Degradation Specifications
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report