# FDA recall D-0021-2026

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2025-09-03.

## Product

Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29.

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0021-2026
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-09-03
- **Report date:** 2025-10-22

- **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-0021-2026

## Citation

> AI Analytics. FDA recall D-0021-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/D-0021-2026. Source: US FDA. Licensed CC0.

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