Lorazepam Tablet
FDA Recall NDC 0904-6007
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Lorazepam (NDC 0904-6007). A significant event, classified as Class II, was initiated on Jan 21, 2025 by Major Pharmaceuticals. The reported reason for this action was: "Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities."
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
January 2025 Class II Recall: Failed impurities/degradation specifications and Sub-potent Drug
Recall Number
Class II Ongoing
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Jan 21, 2025
Feb 26, 2025
82,281 cartons
Recall Profile & Regulatory Data
Event ID
96151
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide U.S. and Puerto rico
Product Description
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
Batch or Lot Expiration Information
Lot# s: N01424, N01425, Exp 03/31/2025; N01659, N01660, Exp 08/31/2025; N01668, 09/2025; N01679, N01704, N01745, Exp 10/31/2025; N01856, Exp 02/28/2026; N01973, Exp 05/31/2026; N02079, Exp 08/31/2026.
Affected Packages Involved in this Recall
0904-6007-60Product
0904-6007-61Product
0904-6008-60Product
0904-6008-61Product
0904-6009-60Product
0904-6009-61Product
January 2025 Class II Recall: Failed impurities/degradation specifications and Sub-potent Drug
Recall Number
Class II Ongoing
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Jan 21, 2025
Feb 26, 2025
94,349 cartons
Recall Profile & Regulatory Data
Event ID
96151
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide U.S. and Puerto rico
Product Description
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.
Batch or Lot Expiration Information
Lot# s: N01419, N01420, N01421, Exp 03/31/2025; N01663, Exp 06/30/2025; N01664, Exp 08/31/2025; N01673, Exp 09/30/2025; N01688, Exp 08/31/2025; N01747, N01748, N01749, Exp 11/30/2025; N01792, Exp 12/31/2025; N01857, Exp 02/28/2026; N01974, Exp 05/31/2026; N02081, Exp 08/31/2026.
Affected Packages Involved in this Recall
0904-6007-60Product
0904-6007-61Product
0904-6008-60Product
0904-6008-61Product
0904-6009-60Product
0904-6009-61Product
January 2025 Class II Recall: Failed impurities/degradation specifications and Sub-potent Drug
Recall Number
Class II Ongoing
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Jan 21, 2025
Feb 26, 2025
27,525 cartons
Recall Profile & Regulatory Data
Event ID
96151
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide U.S. and Puerto rico
Product Description
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
Batch or Lot Expiration Information
Lot# s: N01422, N01423, Exp 03/31/2025; N01661, N01662, Exp 09/30/2025; N01746, N01750, Exp 10/31/2025; N01876, N01877, Exp 03/31/2026; N01899, N01900, N01975, Exp 04/30/2026.
Affected Packages Involved in this Recall
0904-6007-60Product
0904-6007-61Product
0904-6008-60Product
0904-6008-61Product
0904-6009-60Product
0904-6009-61Product
Class III Terminated
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Mar 27, 2013
Jun 12, 2013
1,644 bottles
Recall Profile & Regulatory Data
Event ID
64794
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Legacy Pharmaceutical Packaging LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distribution was made to IN.
Termination Date
Feb 13, 2014
Product Description
Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Batch or Lot Expiration Information
Lot# L-04009 Exp.11/15
Affected Packages Involved in this Recall
0904-6007-60Product
0904-6007-61Product
0904-6008-60Product
0904-6008-61Product
0904-6009-60Product
0904-6009-61Product
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.
