D-0833-2026 Class III Ongoing
FDA drug recall D-0833-2026 was initiated by Supernus Pharmaceuticals, Inc. on August 31, 2026 and is designated Class III. Reason for recall: Failed dissolution specifications. The recall status is ongoing. Affected quantity: 11304 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 9, 2026
- Initiation Date
- August 31, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11304 bottles
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.
Reason for Recall
Failed dissolution specifications.
Distribution Pattern
US Nationwide.
Code Information
Lot# 2145283, Exp Date: 31-Mar-2030.