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Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmac...

FDA Recall #D-0662-2025 — Class II — September 17, 2025

Recall #D-0662-2025 Date: September 17, 2025 Classification: Class II Status: Ongoing

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

Reason for Recall

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

Recalling Firm

Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

13824 tubes

Distribution

Nationwide within the United States

Code Information

Batch # 19252524, Exp Date: May 2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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