CLASS III Drug recall · Reported 22 May 2013 · FDA Enforcement Report
Glenmark Topiramate Tablets, 200 mg recalled
Glenmark Generics Inc. USA is recalling Glenmark Topiramate Tablets, 200 mg, (, distributed nationwide in the US. The recall was initiated on 5 Apr 2013 and the FDA has classified it as Class III.
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-331-2013
- FDA event ID
- 64995
- Recalling firm
- Glenmark Generics Inc. USA, Mahwah, NJ
- Brand
- Topiramate
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Apr 2013
- FDA classified
- 16 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Seizure Medication
Timeline
| 5 Apr 2013 | Recall initiated by company | |
| 16 May 2013 | Classified by FDA | +41 days |
| 22 May 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Product as listed by the FDA
Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Which lots are affected?
Lot# 02123782, Exp 11/14
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 64995This product is part of a recall event; the main page for the event is Glenmark Gabapentin Tablets, a) 600mg bottle recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Glenmark Gabapentin Tablets, a) 600mg bottle recalledGabapentin | Glenmark Generics Inc. USA | Other | Nationwide | |
| CLASS III | Glenmark Pravastatin Sodium Tablets ,40 mg bottle recalledPravastatin Sodium | Glenmark Generics Inc. USA | Other | Nationwide |
More recalls from Glenmark Generics Inc. USA
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine Tablets USP, 150 mg recalled by Glenmark Generics Inc., U | Glenmark Generics Inc. USA | Foreign Material | Nationwide |
| Drug | CLASS III | Glenmark Pravastatin Sodium Tablets ,40 mg bottle recalledPravastatin Sodium | Glenmark Generics Inc. USA | Other | Nationwide |
| Drug | CLASS III | Glenmark Gabapentin Tablets, a) 600mg bottle recalledGabapentin | Glenmark Generics Inc. USA | Other | Nationwide |
| Drug | CLASS III | Montelukast Sodium Tablets, 10 mg (base) recalled | Glenmark Generics Inc. USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Naproxen Tablets recalled by Glenmark Generics Inc., UNaproxen Sodium | Glenmark Generics Inc. USA | Packaging Defects | Nationwide |
Other Topiramate recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Eprontia (topiramate) oral solution, 25 mg/mL recalledEprontia | Azurity Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Topiramate Tablets, USP 50 mg recalled by Unichem Pharmaceuticals UsaTopiramate | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Topiramate Tablets 200 mg recalled by Zydus Pharmaceuticals USATopiramate | Zydus Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS III | Topiramate Tablets, 50 mg-dose blisters recalled | American Health Packaging | Packaging Defects | Nationwide |