Home / Recalls / Supernus Pharmaceuticals, Inc. / D-0758-2026

D-0758-2026 Class III Ongoing

Recalled by Supernus Pharmaceuticals, Inc. — Rockville, MD

FDA drug recall D-0758-2026 was initiated by Supernus Pharmaceuticals, Inc. on July 6, 2026 and is designated Class III. Reason for recall: Failed Dissolution Specifications The recall status is ongoing. Affected quantity: 15,853 bottles.

Recall Details

Product Type: Drugs
Report Date: July 29, 2026
Initiation Date: July 6, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15,853 bottles

Product Description

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 for Recall

Failed Dissolution Specifications

Distribution Pattern

US Nationwide.

Code Information

Lot # 2075801, Exp Date: 31-Oct-2029.