CLASS II Drug recall · Reported 22 Oct 2014 · FDA Enforcement Report
Topiramate Tablets 200 mg recalled by Zydus Pharmaceuticals USA
Zydus Pharmaceuticals USA is recalling Topiramate Tablets 200 mg, distributed nationwide in the US. The recall was initiated on 15 Sep 2014 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-0015-2015
- FDA event ID
- 69387
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Brand
- Topiramate
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Sep 2014
- FDA classified
- 10 Oct 2014
- Reported
- 22 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Seizure Medication
Timeline
| 15 Sep 2014 | Recall initiated by company | |
| 10 Oct 2014 | Classified by FDA | +25 days |
| 22 Oct 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Product as listed by the FDA
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Which lots are affected?
Lot #: MN9828, Expiry: Oct 2015.
Where was it sold?
U.S. 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.
More recalls from Zydus Pharmaceuticals USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Tablets, USP 32 mg recalledMethylprednisolone | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.25 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.125 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | 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 III | Glenmark Topiramate Tablets, 200 mg recalledTopiramate | Glenmark Generics Inc. USA | Other | Nationwide |
| Drug | CLASS III | Topiramate Tablets, 50 mg-dose blisters recalled | American Health Packaging | Packaging Defects | Nationwide |