# FDA recall D-0579-2025

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2025-08-07.

## Product

Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05

## Reason for recall

CGMP Deviations: Presence of a nitrosamine,  N-Nitroso Carvedilol I  Impurity above the current Acceptable Intake Level.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0579-2025
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-07
- **Report date:** 2025-08-20

- **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-0579-2025

## Citation

> AI Analytics. FDA recall D-0579-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0579-2025. Source: US FDA. Licensed CC0.

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