Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Trokendi XR (topiramate) extended-release capsule Recalled by Supernus Pharmaceuticals, Inc. Due to Superpotent Drug: Failure of assay specifications in the...

Date: July 12, 2016
Company: Supernus Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Supernus Pharmaceuticals, Inc. directly.

Affected Products

Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15

Quantity: 17,128 (30-count blister packs)

Why Was This Recalled?

Superpotent Drug: Failure of assay specifications in the capsule.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report