Recall: D-0447-2025

Class II - Potentially Harmful

Class IIClassification

2025-05-07Initiated

OngoingStatus

Alembic Pharmaceuticals LimiteFirm

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

Reason

Failed Impurities/Degradation Specifications

Distribution

US Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.