Clonazepam Tablet, Orally Disintegrating
FDA Recall NDC 49884-310
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Clonazepam (NDC 49884-310). A significant event, classified as Class I, was initiated on Nov 18, 2024 by Par Health Usa, Llc. The reported reason for this action was: "Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength."
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 I Ongoing
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Nov 18, 2024
Jan 15, 2025
72,973 cartons
Recall Profile & Regulatory Data
Event ID
95778
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Endo USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).
Batch or Lot Expiration Information
Lot# s: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401, Exp. 08/31/2026.
Affected Packages Involved in this Recall
49884-306-02Product
49884-307-02Product
49884-308-02Product
49884-309-02Product
49884-310-02Product
49884-307-52Product
Class I Ongoing
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Nov 18, 2024
Jan 15, 2025
9,816 cartons
Recall Profile & Regulatory Data
Event ID
95778
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Endo USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).
Batch or Lot Expiration Information
Lot# 550176501, 550176601, Exp 02/28/2027.
Affected Packages Involved in this Recall
49884-306-02Product
49884-307-02Product
49884-308-02Product
49884-309-02Product
49884-310-02Product
49884-310-52Product
Class I Ongoing
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Nov 18, 2024
Jan 15, 2025
8,029 cartons
Recall Profile & Regulatory Data
Event ID
95778
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Endo USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).
Batch or Lot Expiration Information
Lot# : 550174101, Exp. 01/31/2027.
Affected Packages Involved in this Recall
49884-306-02Product
49884-307-02Product
49884-308-02Product
49884-309-02Product
49884-310-02Product
49884-306-52Product
Class I Ongoing
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Nov 18, 2024
Jan 15, 2025
22,513 cartons
Recall Profile & Regulatory Data
Event ID
95778
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Endo USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).
Batch or Lot Expiration Information
Lot# s: 550145201, Exp. 08/31/2026; 550175901, 550176001, 550176201, Exp. 02/28/2027
Affected Packages Involved in this Recall
49884-306-02Product
49884-307-02Product
49884-308-02Product
49884-309-02Product
49884-310-02Product
49884-309-52Product
Class I Terminated
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Jul 10, 2024
Aug 07, 2024
8,139 cartons
Recall Profile & Regulatory Data
Event ID
94945
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Endo Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Sep 16, 2025
Product Description
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
Batch or Lot Expiration Information
Lot# Lot 550147301, Exp. 08/31/2026
Affected Packages Involved in this Recall
49884-306-02Product
49884-307-02Product
49884-308-02Product
49884-309-02Product
49884-310-02Product
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.
