Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0791-2022·Announced 2022-05-04

Zonisamide Anti-Seizure Capsules Recalled Nationwide for Manufacturing Quality Control Issues

Glenmark Pharmaceuticals is voluntarily recalling 11,136 bottles of Zonisamide Capsules due to manufacturing quality control deviations. No illnesses have been reported.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 voluntary precautionary recall for manufacturing quality control deviations with no reported illnesses or injuries and no identified specific safety hazard, meeting the rubric criteria for Moderate severity.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Zonisamide Capsules USP, 25 mg due to manufacturing quality control deviations identified during current Good Manufacturing Practice (cGMP) inspections. The affected product consists of 11,136 bottles (100-count) with Lot #29200052, which expire on April 30, 2023.

The recalled product was distributed nationwide throughout the United States. The product is used to treat seizures in patients with epilepsy.

Healthcare providers and patients who have received this medication should contact Glenmark Pharmaceuticals or their healthcare provider for further guidance. No illnesses or injuries have been reported in association with this recall.

The recalled product

Product: ZONISAMIDE (ZONISAMIDE)
Brand: ZONISAMIDE
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Category: Drug — Anti-seizure medication
Hazard: manufacturing-deviation
Affected units: 11,136

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 (2)

Lot #: 29200052
Exp 4/30/2023

UPCs (3)

0368462130018
0368462129012
0368462128015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same brand · ZONISAMIDE

Moderate
Drug Recall: Zonisamide Capsules Due to Manufacturing Deviations
FDA (Drugs) · 2022-05-04
Moderate
Prescription Anti-Epilepsy Drug Zonisamide Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-05-04
Moderate
Zonisamide Capsules Recalled by Glenmark Due to CGMP Deviations
FDA (Drugs) · 2021-09-29
Moderate
Zonisamide Capsules Recalled for Manufacturing Deviations
FDA (Drugs) · 2021-09-29

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

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