FDA Drug recall D-0758-2026
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 4…
- FDA Drug
- Class III
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class III recall of Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 4… by Supernus Pharmaceuticals, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0758-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-07-06 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Supernus Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 17772-102-70 |
|---|---|
| ndc | 17772-102-01 |
| ndc | 17772-102-30 |
| ndc | 17772-102-15 |
| ndc | 17772-102-10 |
| ndc | 17772-102-12 |
| ndc | 17772-102-07 |
| ndc | 17772-103-70 |
| ndc | 17772-103-01 |
| ndc | 17772-103-30 |
| ndc | 17772-103-15 |
| ndc | 17772-103-10 |
| ndc | 17772-103-12 |
| ndc | 17772-103-07 |
| ndc | 17772-104-70 |
| ndc | 17772-104-01 |
| ndc | 17772-104-30 |
| ndc | 17772-104-15 |
| ndc | 17772-104-12 |
| ndc | 17772-104-10 |
| ndc | 17772-104-07 |
| ndc | 17772-101-70 |
| ndc | 17772-101-01 |
| ndc | 17772-101-30 |
| ndc | 17772-101-15 |
| ndc | 17772-101-10 |
| ndc | 17772-101-12 |
| ndc | 17772-101-07 |
| code_info | Lot # 2075801, Exp Date: 31-Oct-2029. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0758-2026%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.