August 2026 FDA Recall Drug by Supernus Pharmaceuticals, Inc.
D-0833-2026 - Failed dissolution specifications.

This Class III drug recall was voluntarily initiated by Supernus Pharmaceuticals, Inc. on August 31, 2026 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0833-2026

Reason for Recall
Failed dissolution specifications.
Initiated
08-31-2026
Reported
09-09-2026
Quantity
11304 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99767
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Supernus Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 2145283, Exp Date: 31-Mar-2030.