Supernus Pharmaceuticals, Inc. Trokendi XR Recall (October 2029)
Announced 2026-07-29 · FDA
The recall is for Trokendi XR, topiramate extended-release capsules, 25 mg, 30 capsules, Rx only, manufactured for Supernus Pharmaceuticals, Inc. by Catalent Pharma Solutions. It is due to failed dissolution specifications and involves 15,853 bottles distributed nationwide in the United States; lot number 2075801, expiration date 31-Oct-2029.
| Brand | Supernus Pharmaceuticals, Inc. |
|---|---|
| Product | 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 | Failed Dissolution Specifications |
| Severity | low |
| Units affected | 15853 |
| Distribution | US Nationwide. |
| Agency | FDA |
| Recall / campaign no. | Lot # 2075801, Exp Date: 31-Oct-2029. |
WHAT YOU SHOULD DO
- Do not use any recalled Trokendi XR from lot number 2075801 or with expiration date 31-Oct-2029.
- Contact your pharmacist or healthcare provider for guidance on a replacement or refund and disposal instructions for the recalled product.
- Keep the product packaging, label, and lot number for reference until you have received further instructions.
- Watch for updates from the FDA or Supernus Pharmaceuticals about the recall.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.