Bromfenac Sodium Solution/ Drops
FDA Recall NDC 62332-583
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Bromfenac Sodium (NDC 62332-583). A significant event, classified as Class II, was initiated on Mar 18, 2026 by Alembic Pharmaceuticals Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Mar 18, 2026
Apr 08, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98647
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ALEMBIC PHARMACEUTICALS, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Affected Packages Involved in this Recall
62332-583-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
