# FDA recall D-0582-2025

> **Westminster Pharmaceuticals LLC** · Class II · drug recall initiated 2025-08-06.

## Product

Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10

## Reason for recall

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0582-2025
- **Recalling firm:** Westminster Pharmaceuticals LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-06
- **Report date:** 2025-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Nashville, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0582-2025

## Citation

> AI Analytics. FDA recall D-0582-2025. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/D-0582-2025. Source: US FDA. Licensed CC0.

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