# FDA recall D-0731-2026

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2026-07-23.

## Product

Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

## Reason for recall

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

## Distribution

Nationwide within the United States.

## Key facts

- **Recall number:** D-0731-2026
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-07-23
- **Report date:** 2026-08-05

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0731-2026

## Citation

> AI Analytics. FDA recall D-0731-2026. Retrieved 2026-09-01 from https://api.ai-analytics.org/recall/D-0731-2026. Source: US FDA. Licensed CC0.

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