Reported Aug 20, 2025 · Ongoing
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2),…
Westminster Pharmaceuticals LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Westminster Pharmaceuticals LLC · 1321 Murfreesboro Pike Ste 607 · Nashville, TN · 37217-2693
Is this the product you have?
- Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only
- Manufactured byRenata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh
- Distributed byWestminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 9/30/25 2 Batch # R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, Exp Date: 10/31/2025 3 Batch # R55230151, Exp Date: 11/30/25 4 Batch # R55240011, Exp Date: 12/31/25 5 Batch # R55240021, R55240031, R55240041, R55240051, R55240061, Exp Date: 6/30/26 6 Batch # R55240071, R55240081, R55240091, R55240101, R55240111, R55240121, Exp Date: 7/31/26 - Amount recalled
- 16,672 1000-count bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
This product could cause temporary or reversible health problems — stop using it.
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