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Unrated Drug recall · FDA · Published July 6, 2026

Supernus Trokendi XR 25mg Capsules: Failed Dissolution Risk

Supernus Pharmaceuticals recalls Trokendi XR 25mg capsules due to failed dissolution specifications. This may affect safety and requires checking lot numbers.

🇺🇸 FDA recall #D-0758-2026DrugSupernus Pharmaceuticals ›
✎ GovInfoNow plain-language explainer

Supernus Pharmaceuticals is recalling Trokendi XR 25mg extended-release capsules because they failed dissolution specifications. This could lead to inconsistent drug release and potential safety issues for patients taking the medication. Read more at govinfonow.com/recall/454458-supernus-trokendi-xr-25mg-capsules-failed-dissolution-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/454458-supernus-trokendi-xr-25mg-capsules-failed-dissolution-risk · Updated August 27, 2026 · FDA enforcement record: FDA #D-0758-2026

Cite this page

“Supernus Trokendi XR 25mg Capsules: Failed Dissolution Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/454458-supernus-trokendi-xr-25mg-capsules-failed-dissolution-risk. Based on FDA recall #D-0758-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0758-2026%22&limit=1).

Supernus Pharmaceuticals, Inc. voluntarily recalled Trokendi XR topiramate extended-release capsules due to failed dissolution specifications, the Food and Drug Administration said on July 6, 2026. The Class III recall affects 15,853 bottles distributed nationwide.

How to tell if you have it

  • Brand: Supernus Pharmaceuticals
  • Product: Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules
  • Manufacturer: Catalent Pharma Solutions, Winchester, KY 40391 USA
  • NDC: 17772-101-30
  • Lot #: 2075801
  • Expiration Date: 31-Oct-2029

The hazard

The recall was initiated because the product failed dissolution specifications. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Supernus Pharmaceuticals, Inc. has two other recalls on record since July 12, 2016. Other recent recalls of similar products include Sun Pharmaceutical Lisdexamfetamine Capsules Recall (Oct. 28, 2025), Viatris Xanax XR 3mg Tablets Recall (March 17, 2026), and Lannett Niacin Extended-release Tablets Recall (May 27, 2026).

How to tell if you have this one

Check the product label for 'Trokendi XR 25mg, 30 Capsules, Rx only'. Look for lot number 2075801 with expiration date 31-Oct-2029.

  • Brand
    Supernus Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the lot number 2075801 and expiration date 31-Oct-2029 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 23 days after the firm started it.

1. Firm started the recall: Jul 6, 202612. Published in FDA’s Enforcement Report: Jul 29, 202623. FDA classified it Class III: Aug 11, 202634. Added to GovInfoNow: Aug 27, 202642026
  1. Firm started the recall
  2. Published in FDA’s Enforcement Report
  3. FDA classified it Class III
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0758-2026 (July 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0758-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA