FDA Recall D-0662-2025

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 239 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Batch # 19252524, Exp Date: May 2027

Quantity: 13824 tubes

Reason for recall

CGMP Deviations: Market complaints received for gritty texture (grainy)

Recall record

Recall number: D-0662-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2025-09-17
Classified by FDA Center: 2025-09-24
FDA published: 2025-10-01
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): AZELAIC ACID
Generic name(s): AZELAIC ACID
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-626
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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