March 2026 FDA Recall Bromfenac Sodium by Alembic Pharmaceuticals, Inc.
98647 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Alembic Pharmaceuticals, Inc. on March 18, 2026 for the product Bromfenac Sodium. 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:
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
03-18-2026
04-08-2026
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
ALEMBIC PHARMACEUTICALS, INC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic Pharmaceuticals Limited, Karakhadi- 391 450, Gujarat, India NDC 62332-583-03.
Batch or Lot Expiration Information
Lot# 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026
Lot# 7240278, Exp Date: 5/31/2026.
