The Recall Desk
ModerateFDA (Drugs)·D-0826-2021·Announced 2021-09-29

Zonisamide Capsules Recalled by Glenmark Due to CGMP Deviations

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Zonisamide Capsules USP 100 mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects multiple lot numbers distributed from August 2021.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall issued for CGMP deviations. The source text does not report any illnesses, injuries, or hospitalizations. CGMP violations are manufacturing/quality defects without documented harm, placing this in the Moderate category.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Zonisamide Capsules USP 100 mg due to Current Good Manufacturing Practice (CGMP) deviations. The affected product consists of two package sizes: 100-capsule bottles (NDC 68462-130-01, 216,454 bottles) and 500-capsule bottles (NDC 68462-130-05, 2,166 bottles). Multiple lot numbers are included in this recall, with expiration dates ranging from February 2023 through November 2023.

The affected product was distributed nationwide. Zonisamide is an anti-epileptic medication prescribed to manage seizures. Patients currently taking this medication should not stop taking it without consulting their healthcare provider, as discontinuing an anti-seizure drug can be dangerous.

Patients with affected lot numbers should contact their pharmacy or healthcare provider for guidance. The recalling firm initiated this recall voluntarily, and it was classified as a Class II recall by the FDA. The recall was initiated on August 27, 2021, and was terminated on October 4, 2023.

The recalled product

Product
ZONISAMIDE (ZONISAMIDE)
Brand
ZONISAMIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Anti-epileptic Agent
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

UPCs (3)

  • 0368462130018
  • 0368462129012
  • 0368462128015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same brand · ZONISAMIDE

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

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Same hazard · cgmp deviations

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