Supernus Pharmaceuticals, Inc.
NDC labeler code: 17772
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- TopiramateTopamax, Qudexy XR, Trokendi XR · 4 products
- OxcarbazepineTrileptal, Oxtellar XR · 3 products
- Viloxazine hydrochlorideQelbree · 3 products
- AmantadineGocovri · 2 products
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| April 2, 2021 | NDA211964 | Viloxazine hydrochloride QELBREE | Supernus Pharms |
| August 24, 2017 | NDA208944 | Amantadine GOCOVRI | Supernus Pharms |
| August 16, 2013 | NDA201635 | Topiramate TROKENDI XR | Supernus Pharms |
| October 19, 2012 | NDA202810 | Oxcarbazepine OXTELLAR XR | Supernus Pharms |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
August 31, 2026 · Class III · Ongoing · D-0833-2026 · Topiramate
Failed dissolution specifications.
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 2085
-
July 6, 2026 · Class III · Ongoing · D-0758-2026 · Topiramate
Failed Dissolution Specifications
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 U
2021
-
March 15, 2021 · Class II · Terminated · D-0570-2021 · Topiramate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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,
2016
-
July 12, 2016 · Class II · Terminated · D-0112-2017 · Topiramate
Superpotent Drug: Failure of assay specifications in the capsule.
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 2
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
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Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026