Alembic Pharmaceuticals Limited recalls Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., B
Recalled June 4, 2025 · FDA recall D-0447-2025 · Alembic Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications · FDA Class II
Units
N/A
Sold at
US Nationwide
Description
Failed Impurities/Degradation Specifications
Product
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
Manufacturer(s)
Alembic Pharmaceuticals Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →