← FDA ENFORCEMENT
D-0833-2026Class III

Supernus Pharmaceuticals, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Supernus Pharmaceuticals, Inc.
Product type
Drug
Status
Ongoing
Report date
2026-09-09
Distribution
US Nationwide.
Firm state
MD
Product quantity
11304 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed dissolution specifications.

Product description

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.

Code / lot info

Lot# 2145283, Exp Date: 31-Mar-2030.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →