Supernus Pharmaceuticals, Inc.: Trokendi Xr, Topiramate Extended-release Capsules, 25mg, 30 Capsules

Supernus Pharmaceuticals is recalling 25mg Trokendi XR (topiramate extended-release) capsules in 30-count bottles because the medication failed to dissolve properly in the body as specified. The affected product was distributed nationwide across all U.S. states and territories. This is a Class III recall, meaning use of the product is unlikely to cause serious health problems, but the medication may not work as intended.

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
Classification
Class III
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/a6910e63-82bc-45e0-b315-09b0b5b519f4