FDA Drug recall D-0570-2021
Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40…
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40… by Cardinal Health, citing CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0570-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-15 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | FL, GA, SC |
Product
Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30
Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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 | 1741214 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0570-2021%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.