CLASS III ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
Trokendi XR, (topiramate) extended-release capsules, 50 mg recalled
Supernus Pharmaceuticals is recalling Trokendi XR, (topiramate) extended-release capsules, 50 mg, distributed nationwide in the US. The recall was initiated on 31 Aug 2026 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-0833-2026
- FDA event ID
- 99767
- Recalling firm
- Supernus Pharmaceuticals, Rockville, MD
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 31 Aug 2026
- FDA classified
- 3 Sep 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 31 Aug 2026 | Recall initiated by company | |
| 3 Sep 2026 | Classified by FDA | +3 days |
| 9 Sep 2026 | 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
Failed dissolution specifications.
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 capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Failed dissolution specifications.
Which lots are affected?
Lot# 2145283, Exp Date: 31-Mar-2030.
Where was it sold?
US 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.
More recalls from Supernus Pharmaceuticals
All 3| 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 II | Trokendi XR (topiramate) extended-release capsule, 50mg recalledTrokendi Xr | Supernus Pharmaceuticals | Potency & Assay | Nationwide |