CLASS II Drug recall · Reported 4 May 2022 · FDA Enforcement Report
Zonisamide Capsules, USP, 100 mg recalled by Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Inc., USA is recalling Zonisamide Capsules, USP, 100 mg, distributed nationwide in the US. The recall was initiated on 25 Apr 2022 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-0793-2022
- FDA event ID
- 90029
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Brand
- Zonisamide
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 25 Apr 2022
- FDA classified
- 27 Apr 2022
- Reported
- 4 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 25 Apr 2022 | Recall initiated by company | |
| 27 Apr 2022 | Classified by FDA | +2 days |
| 4 May 2022 | Published in enforcement report | +7 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, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Where it was distributed
USA nationwide
Questions about this recall
Why was it recalled?
cGMP deviations
Which lots are affected?
a) Lot #: 29200053, Exp 4/30/2023; b) Lot #: 29200054, Exp 4/30/2023
Where was it sold?
USA 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 90029This product is part of a recall event; the main page for the event is Zonisamide Capsules, USP, 50 mg recalled by Glenmark Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Zonisamide Capsules, USP, 50 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Zonisamide Capsules USP, 25 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | 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, 25 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zonisamide Capsules, USP, 50 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zonisamide Capsules USP 100 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zonisamide Capsules USP 50 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |