The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0792-2022·Announced 2022-05-04

Drug Recall: Zonisamide Capsules Due to Manufacturing Deviations

Glenmark Pharmaceuticals is recalling 12,003 bottles of Zonisamide 50 mg capsules nationwide due to manufacturing deviations.

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: The recall is FDA Class II and was voluntary with no reported illnesses or injuries. The hazard is a manufacturing process deviation without a specific confirmed product defect, making this a precautionary recall. Voluntary precautionary recalls are classified as Moderate severity.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles. The recall affects 12,003 bottles distributed nationwide in the United States.

The recall was initiated due to cGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. This was a voluntary recall initiated by the firm and classified by the FDA as Class II.

The recalled product is identified by Lot #29200064 with an expiration date of 5/31/2023. Patients currently taking this medication should contact their healthcare provider for guidance before discontinuing or replacing their medication. Healthcare providers and pharmacists should identify and quarantine any bottles matching the recalled lot number.

The recalled product

Product
ZONISAMIDE (ZONISAMIDE)
Brand
ZONISAMIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription / Anti-seizure
Hazard
Affected units
12,003

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 #: 29200064
  • Exp 5/31/2023

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 →

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