Supernus Pharmaceuticals, Inc.: Trokendi Xr, (topiramate) Extended-release Capsules, 50 Mg, 30 Capsules

Recalling firm
Supernus Pharmaceuticals, Inc.
Product
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.
Classification
Class III
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-08-31
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/b5349abd-d811-480f-828f-ae7c62210f75