CLASS III ONGOING Drug recall · Reported 29 Jul 2026 · FDA Enforcement Report
Trokendi XR, topiramate extended-release capsules, 25mg recalled
Supernus Pharmaceuticals is recalling Trokendi XR, topiramate extended-release capsules, 25mg, distributed nationwide in the US. The recall was initiated on 6 Jul 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-0758-2026
- FDA event ID
- 99375
- Recalling firm
- Supernus Pharmaceuticals, Rockville, MD
- Brand
- Trokendi Xr
- Manufacturer
- Supernus Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 6 Jul 2026
- FDA classified
- 11 Aug 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 6 Jul 2026 | Recall initiated by company | |
| 29 Jul 2026 | Published in enforcement report | +23 days |
| 11 Aug 2026 | Classified by FDA | +13 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, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot # 2075801, Exp Date: 31-Oct-2029.
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, 50 mg recalled | Supernus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Trokendi XR (topiramate) extended-release capsule, 50mg recalledTrokendi Xr | Supernus Pharmaceuticals | Potency & Assay | Nationwide |
Other Topiramate recalls
All 8| 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 | Trokendi XR (topiramate) extended-release capsules 100 mg recalledTrokendi Xr | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Trokendi XR (topiramate) extended-release capsule, 50mg recalledTrokendi Xr | Supernus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Topiramate Tablets 200 mg recalled by Zydus Pharmaceuticals USATopiramate | Zydus Pharmaceuticals USA | Other | Nationwide |