The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0793-2022·Announced 2022-05-04

Prescription Anti-Epilepsy Drug Zonisamide Recalled for Manufacturing Deviations

Glenmark Pharmaceuticals is recalling Zonisamide Capsules (100 mg) due to current good manufacturing practice (cGMP) deviations. Two lots were distributed nationwide.

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 a voluntary, firm-initiated Class II recall for manufacturing compliance deviations with no reported illnesses or injuries. The hazard is a manufacturing process issue rather than a contamination or defect with evidence of harm, consistent with precautionary recalls classified as Moderate.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Zonisamide Capsules, USP, 100 mg, due to deviations from current good manufacturing practices (cGMP). The affected product is packaged in two sizes: 100-count bottles (NDC 68462-130-01) and 500-count bottles (NDC 68462-130-05).

Two lots are subject to recall: Lot 29200053 with approximately 7,044 bottles of the 100-count size (expiring 4/30/2023), and Lot 29200054 with approximately 1,014 bottles of the 500-count size (expiring 4/30/2023). Both lots were distributed throughout the United States.

Zonisamide is a prescription anti-epilepsy medication. Patients currently taking this medication who have bottles from the affected lots should contact their healthcare provider or pharmacist. Do not stop taking Zonisamide without medical guidance, as abrupt discontinuation could result in breakthrough seizures or loss of seizure control.

The recalled product

Product
ZONISAMIDE (ZONISAMIDE)
Brand
ZONISAMIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Anti-Epilepsy
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 (3)

  • a) Lot #: 29200053
  • Exp 4/30/2023
  • b) Lot #: 29200054

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 →

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