FDA Drug recall D-0833-2026
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, K…
- FDA Drug
- Class III
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class III recall of Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, K… by Supernus Pharmaceuticals, citing failed dissolution specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0833-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-08-31 |
| Published | 2026-09-09 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Supernus Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
Failed dissolution specifications.
Identifiers
| code_info | Lot# 2145283, Exp Date: 31-Mar-2030. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
Other recalls by Supernus Pharmaceuticals
- Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 4…
FDA Drug · Class III · 2026-07-29 · Supernus Pharmaceuticals - Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winche…
FDA Drug · Class II · 2016-10-26 · Supernus Pharmaceuticals
All Supernus Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0833-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.