# FDA recall D-0662-2025

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2025-09-17.

## 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

## Reason for recall

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

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0662-2025
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-09-17
- **Report date:** 2025-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0662-2025

## Citation

> AI Analytics. FDA recall D-0662-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0662-2025. Source: US FDA. Licensed CC0.

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