FDAFDA · Food and drugs·Recall number D-0582-2025
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
Published August 20, 2025 · Recall initiated: August 6, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Westminster Pharmaceuticals LLC
- Distributor
- Nationwide in the USA.
- Lot
- Batch # R56240011, Exp Date: 2/28/26; Batch # R56240021, R56240031, Exp Date: 3/31/26; Batch # R56240041, R56240051, R56240061, Exp Date: 4/30/26; Batch # R56240071, Exp Date: 7/31/26
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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