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
- manufacturing-deviation
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.
Related recalls
Same brand · ZONISAMIDE
- ModeratePrescription Anti-Epilepsy Drug Zonisamide Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-05-04
- ModerateDrug Recall: Zonisamide Capsules Due to 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
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27