Trokendi XR recall (Supernus Pharmaceuticals, Inc.)
DrugClass IIIOngoing
Summary: Supernus Pharmaceuticals, Inc. is recalling 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: Failed dissolution specifications.
What is being recalled
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.
Why
Failed dissolution specifications.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot# 2145283, Exp Date: 31-Mar-2030.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0833-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | August 31, 2026 |
| Reported | September 9, 2026 |
| Company | Supernus Pharmaceuticals, Inc. |
| Company location | Rockville, MD, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 11304 bottles |
More recalls from Supernus Pharmaceuticals, Inc. · all drug recalls · recalls from August 2026