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Class IIIOngoing

Supernus Pharmaceuticals, Inc. recalls Trokendi XR

Recall date · record updated Sep 9, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Supernus Pharmaceuticals, Inc.
Reason
Failed dissolution specifications.
Hazard
FDA Class III: not likely to cause adverse health consequences (FDA definition).
Who’s affected
US Nationwide.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99767…

Products

  1. 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.

    Codes/lots: Lot# 2145283, Exp Date: 31-Mar-2030.Quantity: 11304 bottlesRecall no. D-0833-2026Class III

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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