Class III · Low risk Ongoing
Trokendi XR
Reason Failed Dissolution Specifications
Trokendi XR
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Superpotent Drug: Failure of assay specifications in the capsule.
What was recalled
Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15
- Recalling firm
- Supernus Pharmaceuticals, Inc.
- NDC code
- 17772-102-15
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0112-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Topiramate recalls
See all
Class III · Low risk Terminated
Eprontia
Reason Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class III · Low risk Terminated
Topiramate Tablets
Reason Discoloration
Class II · Moderate risk Terminated
Trokendi XR
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Topiramate 25mg Tabs White/round tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.