Class IIIOngoing
Supernus Pharmaceuticals, Inc. recalls Trokendi XR
Recall date · record updated Jul 29, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)
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=99375…
Products
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.
Codes/lots: Lot # 2075801, Exp Date: 31-Oct-2029.Quantity: 15,853 bottlesRecall no. D-0758-2026Class III
Update history
- 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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