Metoprolol Tartrate Tablet
FDA Recall NDC 69367-355
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Metoprolol Tartrate (NDC 69367-355). A significant event, classified as Class II, was initiated on Aug 06, 2025 by Westminster Pharmaceuticals, Llc. The reported reason for this action was: "CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Aug 06, 2025
Aug 20, 2025
4,456 1000-count bottles
Recall Profile & Regulatory Data
Event ID
97395
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Westminster Pharmaceuticals LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
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
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
69367-354-01Product
69367-354-10Product
69367-355-01Product
69367-355-10Product
Class II Ongoing
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Aug 06, 2025
Aug 20, 2025
16,672 1000-count bottles
Recall Profile & Regulatory Data
Event ID
97395
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Westminster Pharmaceuticals LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
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
Batch or Lot Expiration Information
Batch# R55230021, R55230031, R55230041, Exp Date: 9/30/25
Batch# R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, Exp Date: 10/31/2025
Batch# R55230151, Exp Date: 11/30/25
Batch# R55240011, Exp Date: 12/31/25
Batch# R55240021, R55240031, R55240041, R55240051, R55240061, Exp Date: 6/30/26
Batch# R55240071, R55240081, R55240091, R55240101, R55240111, R55240121, Exp Date: 7/31/26
Affected Packages Involved in this Recall
69367-354-01Product
69367-354-10Product
69367-355-01Product
69367-355-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
