Class II Recall Issued for Bromfenac Ophthalmic Drops Due to Degradation Issues

Alembic Pharmaceuticals has voluntarily initiated a nationwide recall of bromfenac ophthalmic solution 0.09%, packaged in 1.7 mL bottles, following concerns over the product’s failure to meet impurity and degradation specifications. The affected lots—7230309, 7230310, and 7230311—are labeled with an expiration date of May 31, 2025. While the quantity distributed is currently unspecified, the recalled product was made in India and marketed under NDC 62332-508-17 for U.S. prescription use.

The US Food and Drug Administration (FDA) has classified this action as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse consequences is remote. The recall, designated under event ID 96836 and recall number D-0447-2025, was initiated by Alembic Pharmaceuticals Limited on May 7, 2025, with notification to consignees made via letter. As of now, the recall remains ongoing and has not been associated with an official press release.

Bromfenac Ophthalmic Solution is a nonsteroidal anti-inflammatory drug (NSAID) prescribed to reduce postoperative inflammation and pain in patients undergoing cataract surgery. Pharmacists are advised to check their inventory for the specified lots and follow the recall instructions provided by the manufacturer to ensure patient safety and compliance.