The Recall Desk
ModerateFDA (Drugs)·D-0825-2021·Announced 2021-09-29

Zonisamide Capsules Recalled for Manufacturing Deviations

Glenmark Pharmaceuticals is recalling Zonisamide Capsules 50 mg nationwide due to manufacturing deviations. The recall affects approximately 15,936 bottles across multiple lots with expiration dates in May 2022.

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 initiated voluntarily by the manufacturer due to manufacturing deviations. The source text does not report any illnesses, injuries, or adverse events; the hazard is related to potential lack of assurance in the manufacturing process rather than a known safety threat. Per the rubric, CGMP deviations without reported harm or Class I status warrant a score of 2 (Moderate).

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Zonisamide Capsules USP 50 mg (NDC 68462-129-01) due to current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The affected product is distributed nationwide.

Specifically, the recall involves three lots: 29190043, 29190044, and 29190045, all expiring May 31, 2022. Approximately 15,936 bottles are affected. The recall was initiated by the firm on August 27, 2021, and classified as a voluntary, firm-initiated Class II recall by the FDA on September 21, 2021.

Patients currently taking affected doses should consult their healthcare provider before discontinuing use. Healthcare providers and patients should report any adverse events to the FDA's MedWatch program. The recall was terminated on October 4, 2023.

The recalled product

Product
ZONISAMIDE (ZONISAMIDE)
Brand
ZONISAMIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Anti-epileptic / Prescription Capsule
Hazard
Affected units
15,936

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)

  • Lots: 29190043 Exp. 05/31/2022
  • 29190044 Exp. 05/31/2022
  • 29190045 Exp. 05/31/2022

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

See all →

Same hazard · cgmp violation

See all →