Supernus Pharmaceuticals, Inc. Trokendi XR Recall
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot # 2075801, Exp Date: 31-Oct-2029. |
|---|---|
| Lot / date codes | Lot # 2075801, Exp Date: 31-Oct-2029. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.