Trokendi XR Recall: Topiramate Capsule Assay Failure
Supernus Pharmaceuticals recalls Trokendi XR 50mg capsules due to assay specification failures. Check lot #426636, exp 4/22/18.
Use caution until it’s fixed
Superpotent Drug: Failure of assay specifications in the capsule.
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What happened, in plain English
Supernus Pharmaceuticals is recalling one lot of Trokendi XR (topiramate) extended-release capsules because the drug failed assay specifications. The affected product is a 50mg, 30-count blister pack manufactured by Catalent Pharma Solutions. This means the actual amount of active ingredient in the capsules may not match what is listed on the label. Read more at govinfonow.com/recall/42550-trokendi-xr-recall-topiramate-capsule-assay-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/42550-trokendi-xr-recall-topiramate-capsule-assay-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-0112-2017
Cite this page
“Trokendi XR Recall: Topiramate Capsule Assay Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42550-trokendi-xr-recall-topiramate-capsule-assay-failure. Based on FDA recall #D-0112-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0112-2017%22&limit=1).
Why it’s dangerous
The hazard is a failure to meet assay specifications, meaning the concentration of topiramate in the capsules may be higher or lower than intended. Taking medication with incorrect potency can lead to ineffective treatment or unexpected side effects, though the record does not specify immediate physical injury mechanisms like fire or trauma.
Who’s affected
Patients currently taking Trokendi XR for migraine prevention or epilepsy who possess the specific recalled lot number are at risk of receiving medication with incorrect potency. The recall affects units distributed nationwide.
How to tell if you have this one
Look for Trokendi XR (topiramate) extended-release capsules, 50mg strength, in a 30-count blister pack. Check the label for NDC 17772-102-15, Lot # 426636, and an expiration date of 4/22/18. The product was manufactured by Catalent Pharma Solutions in Winchester, KY.
- Brand
Trokendi XR- Category
Drug
What to do — step by step
Check your medication
Verify if your Trokendi XR capsules match Lot # 426636 and expiration date 4/22/18.
Contact your pharmacist
If you have the recalled lot, speak with your pharmacy or healthcare provider immediately for instructions on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0112-2017 (July 12, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0112-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.