Class III · Low risk
Trokendi XR
Failed Dissolution Specifications
Trokendi XR
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed dissolution specifications.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.
Affected NDC
17772-0102-30
Compare with the code on your package — it is the most precise check available.
Drug: Topiramate
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Trokendi XR topiramate NDC 17772-0102 |
50 mg/1 | Capsule, Extended Release Oral |
Supernus Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Supernus Pharmaceuticals, Inc.
- NDC code
- 17772-102-30
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0833-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Topiramate recalls
See all
Class III · Low risk
Eprontia (topiramate)
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
Topiramate Tablets
Discoloration
Class II · Moderate risk
Trokendi XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Topiramate 25mg Tabs White/round tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Other recalls by Supernus Pharmaceuticals, Inc.
All 2026 recalls
Class III · Low risk
Trokendi XR
Failed Dissolution Specifications
Class II · Moderate risk
Trokendi XR
Superpotent Drug: Failure of assay specifications in the capsule.
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