Supernus Pharmaceuticals, Inc.: Trokendi Xr, Topiramate Extended-release Capsules, 25mg, 30 Capsules
Recall Summary Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) 25mg extended-release capsules in 30-capsule bottles nationwide because the medication failed to meet dissolution specifications, meaning the capsules may not break down properly in the body. This recall affects the prescription drug product with NDC 17772-101-30 that was manufactured by Catalent Pharma Solutions in Winchester, Kentucky. The recall applies to all U.S. states and Washington, D.C.
- Recalling firm
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-07-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/bb903a09-c878-4563-85fc-8cbe8c6ff8a1