The Recall Desk

FDA (Drugs) recall action 97395

Westminster Pharmaceuticals LLC recalled 2 products on 2025-08-20

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-08-20
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Drugs)··2025-08-20

    Metoprolol tartrate tablets recalled for nitrosamine above acceptable daily intake level

    Metoprolol Tartrate Tablets USP, 50 mg, distributed by Westminster Pharmaceuticals, are recalled nationwide after N-nitroso-metoprolol was found above the established Acceptable Daily Intake. 16,672 bottles are affected.

    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
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2025-08-20

    Metoprolol tartrate 100 mg tablets exceed the nitrosamine daily intake level

    Metoprolol Tartrate Tablets USP 100 mg distributed by Westminster Pharmaceuticals are being recalled because N-nitroso-metoprolol was present above the established Acceptable Daily Intake level. 4,456 bottles affected.

    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
    Category
    Distribution
    0 states