May 2025 FDA Recall Bromfenac Ophthalmic Solution 0.09% by Alembic Pharmaceuticals Limited
D-0447-2025 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Alembic Pharmaceuticals Limited on May 7, 2025 for the product Bromfenac Ophthalmic Solution 0.09%. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0447-2025

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
05-07-2025
Reported
06-04-2025
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96836
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Alembic Pharmaceuticals Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025

Affected Packages Involved in this Recall

62332-508-17 Bromfenac Ophthalmic Solution 0.09%