Westminster Pharmaceuticals LLC recalls Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapar

Recalled August 20, 2025 · FDA recall D-0582-2025 · Westminster Pharmaceuticals

Hazard

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

Units

4,456 1000-count bottles

Sold at

Nationwide in the USA.

Description

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

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

Manufacturer(s)

Westminster Pharmaceuticals LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →