Westminster Pharmaceuticals LLC: Drug Recall

Recall #D-0581-2025 · 08/06/2025

Class II: Risk

Recall Details

Recall Number: D-0581-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Westminster Pharmaceuticals LLC
Status: Ongoing
Date Initiated: 08/06/2025
Location: Nashville, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16,672 1000-count bottles

Reason for Recall

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

Product Description

Metoprolol Tartrate Tablets, USP, 50 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 69367-354-10

Distribution Pattern

Nationwide in the USA.

Other Recalls by Westminster Pharmaceuticals LLC

Class II: Risk 08/06/2025

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

View all recalls by Westminster Pharmaceuticals LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.