FDA recall, , Low risk
Trokendi XR, Topiramate Extended-Release Capsules
Trokendi XR, topiramate extended-release capsules failed dissolution specifications.
Summary by Recall Canary from the FDA notice
What happened
Supernus Pharmaceuticals, Inc., of Rockville, Maryland, recalled Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, manufactured by Catalent Pharma Solutions, Winchester, KY 40391 USA, because the product failed dissolution specifications. The company began the recall on July 6, 2026, and the FDA added it to the Enforcement Report on July 17, 2026. The recall affected 15,853 bottles distributed nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 17772-101-30
- Lot code
- 2075801
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Supernus Pharmaceuticals, Inc.Rockville, Maryland
- Hazard
- Drug dissolving problem
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99375
- Recall number
- D-0758-2026
- Quantity recalled
- 15,853 bottles
All recalls from Supernus Pharmaceuticals, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
