CLASS II Drug recall · Reported 26 Oct 2016 · FDA Enforcement Report
Trokendi XR (topiramate) extended-release capsule, 50mg recalled
Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) extended-release capsule, 50mg, distributed nationwide in the US. The recall was initiated on 12 Jul 2016 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-0112-2017
- FDA event ID
- 74988
- Recalling firm
- Supernus Pharmaceuticals, Rockville, MD
- Brand
- Trokendi Xr
- Manufacturer
- Supernus Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jul 2016
- FDA classified
- 20 Oct 2016
- Reported
- 26 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 12 Jul 2016 | Recall initiated by company | |
| 20 Oct 2016 | Classified by FDA | +100 days |
| 26 Oct 2016 | 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
Superpotent Drug: Failure of assay specifications in the capsule.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Superpotent Drug: Failure of assay specifications in the capsule.
Which lots are affected?
Lot # 426636, Exp 4/22/18
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 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 Supernus Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Trokendi XR, (topiramate) extended-release capsules, 50 mg recalled | Supernus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Trokendi XR, topiramate extended-release capsules, 25mg recalledTrokendi Xr | Supernus Pharmaceuticals | Potency & Assay | Nationwide |
Other Topiramate recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Trokendi XR, topiramate extended-release capsules, 25mg recalledTrokendi Xr | Supernus Pharmaceuticals | Potency & Assay | Nationwide |
| 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 | Trokendi XR (topiramate) extended-release capsules 100 mg recalledTrokendi Xr | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Topiramate Tablets 200 mg recalled by Zydus Pharmaceuticals USATopiramate | Zydus Pharmaceuticals USA | Other | Nationwide |