Westminster Pharmaceuticals LLC recalls Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara
Recalled August 20, 2025 · FDA recall D-0581-2025 · Westminster Pharmaceuticals
Hazard
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. · FDA Class II
Units
16,672 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, 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
Manufacturer(s)
Westminster Pharmaceuticals LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →