CLASS II Drug recall · Reported 29 Sep 2021 · FDA Enforcement Report
Zonisamide Capsules USP 50 mg recalled by Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Inc., U is recalling Zonisamide Capsules USP 50 mg, distributed nationwide in the US. The recall was initiated on 27 Aug 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0825-2021
- FDA event ID
- 88591
- Recalling firm
- Glenmark Pharmaceuticals Inc., U, Mahwah, NJ
- Brand
- Zonisamide
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Aug 2021
- FDA classified
- 21 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 27 Aug 2021 | Recall initiated by company | |
| 21 Sep 2021 | Classified by FDA | +25 days |
| 29 Sep 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Where it was distributed
Nationwide.
Questions about this recall
Is Zonisamide Capsules USP 50 mg recalled?
Yes. Glenmark Pharmaceuticals Inc., U recalled Zonisamide Capsules USP 50 mg on 27 Aug 2021. The recall is Class II and its status is Terminated. Recall number D-0825-2021.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lots: 29190043 Exp. 05/31/2022; 29190044 Exp. 05/31/2022; 29190045 Exp. 05/31/2022
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Glenmark Pharmaceuticals Inc., U
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|---|---|---|---|---|---|
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| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., U | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., U | Packaging Defects | Nationwide |
Other Zonisamide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zonisamide Capsules USP, 100 mg recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zonisamide Capsules, USP, 100 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zonisamide Capsules USP, 25 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zonisamide Capsules, USP, 50 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zonisamide Capsules USP 100 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |