Zonisamide Capsule
FDA Recall NDC 68462-129
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 Zonisamide (NDC 68462-129). A significant event, classified as Class II, was initiated on Apr 25, 2022 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "cGMP deviations"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
cGMP deviations
Apr 25, 2022
May 04, 2022
12,003 bottles
Recall Profile & Regulatory Data
Event ID
90029
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Product Description
Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-129-01
Batch or Lot Expiration Information
Lot# : 29200064, Exp 5/31/2023
Affected Packages Involved in this Recall
68462-128-01Product
68462-128-05Product
68462-129-01Product
68462-129-05Product
68462-130-01Product
68462-130-05Product
Class II Completed
cGMP deviations
Apr 25, 2022
May 04, 2022
a) 7,044 bottles; b) 1,014 bottles
Recall Profile & Regulatory Data
Event ID
90029
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Product Description
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Batch or Lot Expiration Information
Lot# a)
Lot# : 29200053, Exp 4/30/2023; b)
Lot# : 29200054, Exp 4/30/2023
Affected Packages Involved in this Recall
68462-128-01Product
68462-128-05Product
68462-129-01Product
68462-129-05Product
68462-130-01Product
68462-130-05Product
Class II Completed
cGMP deviations
Apr 25, 2022
May 04, 2022
11,136 bottles
Recall Profile & Regulatory Data
Event ID
90029
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Product Description
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01
Batch or Lot Expiration Information
Lot# : 29200052, Exp 4/30/2023
Affected Packages Involved in this Recall
68462-128-01Product
68462-128-05Product
68462-129-01Product
68462-129-05Product
68462-130-01Product
68462-130-05Product
Class II Terminated
CGMP Deviations
Aug 27, 2021
Sep 29, 2021
a) 216,454 bottles; b) 2166 bottles
Recall Profile & Regulatory Data
Event ID
88591
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Oct 04, 2023
Product Description
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05
Batch or Lot Expiration Information
Lot# Lots: a) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023; 29200030 Exp. 05/31/2023; 29200031 Exp. 05/31/2023; 29200032 Exp. 05/31/2023; 29200033 Exp. 06/30/2023; 29200037 Exp. 06/30/2023; 29200038 Exp. 06/30/2023; 29200039 Exp. 07/31/2023; 29200041 Exp. 07/31/2023; 29200042 Exp. 07/31/2023; 29200048 Exp. 08/31/2023; 29200049 Exp. 08/31/2023; 29200050 Exp. 08/31/2023; 29200072 Exp. 11/30/2023; 29200073 Exp. 11/30/2023; 29200074 Exp. 11/30/2023; 29200075 Exp. 11/30/2023; 29200076 Exp. 11/30/2023; b) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023
Affected Packages Involved in this Recall
68462-128-01Product
68462-128-05Product
68462-129-01Product
68462-129-05Product
68462-130-01Product
68462-130-05Product
Class II Terminated
CGMP Deviations
Aug 27, 2021
Sep 29, 2021
15936 bottles
Recall Profile & Regulatory Data
Event ID
88591
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Oct 04, 2023
Product Description
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Batch or Lot Expiration Information
Lot# Lots: 29190043 Exp. 05/31/2022; 29190044 Exp. 05/31/2022; 29190045 Exp. 05/31/2022
Affected Packages Involved in this Recall
68462-128-01Product
68462-128-05Product
68462-129-01Product
68462-129-05Product
68462-130-01Product
68462-130-05Product
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.
