# FDA recall D-0092-2024

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2023-10-23.

## Product

Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.

## Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0092-2024
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-10-23
- **Report date:** 2023-11-15

- **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-0092-2024

## Citation

> AI Analytics. FDA recall D-0092-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0092-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*