# FDA recall D-0002-2025

> **Glenmark Pharmaceuticals Inc., USA** · Class III · drug recall initiated 2024-09-30.

## Product

Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

## Reason for recall

Defective Container: Firm received complaints of broken tube at the seal.

## Distribution

Nationwide in the US.

## Key facts

- **Recall number:** D-0002-2025
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-09-30
- **Report date:** 2024-10-09

- **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-0002-2025

## Citation

> AI Analytics. FDA recall D-0002-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0002-2025. Source: US FDA. Licensed CC0.

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