Metoprolol Tartrate Tablets recalled over manufacturing violations

Recall date

August 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0582-2025

FDA classification

Class II

Brand / firm

Westminster Pharmaceuticals LLC

Sold / distributed

Nationwide in the USA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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