# FDA recall D-0341-2025

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2025-03-13.

## Product

Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.

## Reason for recall

CGMP Deviations

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0341-2025
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-13
- **Report date:** 2025-04-16

- **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-0341-2025

## Citation

> AI Analytics. FDA recall D-0341-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0341-2025. Source: US FDA. Licensed CC0.

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