Reported Aug 20, 2025 · Ongoing
Metoprolol Tartrate Tablets, USP, 100 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, 100 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 69367-355-10
- Lot codes and dates
- Batch # R56240011
- Exp Date
2/28/26Batch # R56240021R56240031
- Exp Date
3/31/26Batch # R56240041R56240051R56240061
- Exp Date
4/30/26Batch # R56240071
- Exp Date7/31/26
- Amount recalled
- 4,456 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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