Azelaic Acid Gel
FDA Recall NDC 68462-626
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Azelaic Acid (NDC 68462-626). A significant event, classified as Class II, was initiated on Sep 17, 2025 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "CGMP Deviations: Market complaints received for gritty texture (grainy)"
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
CGMP Deviations: Market complaints received for gritty texture (grainy)
Sep 17, 2025
Oct 01, 2025
13824 tubes
Recall Profile & Regulatory Data
Event ID
97619
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52
Batch or Lot Expiration Information
Batch# 19252524, Exp Date: May 2027
Affected Packages Involved in this Recall
68462-626-52Product
Class II Ongoing
CGMP Deviations
Jul 22, 2024
Aug 07, 2024
14,004 cartons
Recall Profile & Regulatory Data
Event ID
95022
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52.
Batch or Lot Expiration Information
Lot# 19241453; Exp MARCH 2026
Affected Packages Involved in this Recall
68462-626-52Product
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.
