Food, drugs, devices › Supernus Pharmaceuticals, Inc.
Drug recall: Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharm
FDA enforcement event 74988 is a drug recall by Supernus Pharmaceuticals, Inc. of Rockville, MD, initiated 12 Jul 2016 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 46% of the 288 drug enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 26 Feb 2019. Initiation: voluntary: firm initiated. Supernus Pharmaceuticals, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Supernus Pharmaceuticals, Inc., Rockville, MD.
Reason for recall
"Superpotent Drug: Failure of assay specifications in the capsule."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0112-2017 | Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15 | 17,128 (30-count blister packs) | Class II | Terminated | 26 Oct 2016 |
Context
Other enforcement events for Supernus Pharmaceuticals, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 31 Aug 2026 | Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solut | Drug | Class III | 1 |
| 6 Jul 2026 | Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solution | Drug | Class III | 1 |
All 3 events for Supernus Pharmaceuticals, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Superpotent Drug: Failure of assay specifications in the capsule."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Feb 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.