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.
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 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
- 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 →Related recalls
Same brand · ZONISAMIDE
- ModerateDrug Recall: Zonisamide Capsules Due to Manufacturing Deviations
FDA (Drugs) · 2022-05-04
- ModeratePrescription Anti-Epilepsy Drug Zonisamide Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-05-04
- ModerateZonisamide Capsules Recalled for Manufacturing Deviations
FDA (Drugs) · 2021-09-29
- ModerateZonisamide Capsules Recalled by Glenmark Due to CGMP Deviations
FDA (Drugs) · 2021-09-29
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