# FDA recall D-0462-2025

> **Glenmark Pharmaceuticals Inc., USA** · Class III · drug recall initiated 2025-05-19.

## Product

Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90

## Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.

## Distribution

Nationwide USA and PR

## Key facts

- **Recall number:** D-0462-2025
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-19
- **Report date:** 2025-06-18

- **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-0462-2025

## Citation

> AI Analytics. FDA recall D-0462-2025. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/D-0462-2025. Source: US FDA. Licensed CC0.

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