FDA-Drug2026-09-09Class IIIPROCESSING DEFECT
Supernus Trokendi XR topiramate capsules recalled for failed dissolution specifications
What this means
Supernus Pharmaceuticals is recalling one lot of Trokendi XR (topiramate) 50 mg extended-release capsules because the medication did not dissolve as designed. When a medication fails to dissolve properly, the body may not absorb the full dose, potentially reducing its effectiveness.
- Check if your medication matches lot #2145283 with expiration date 31-Mar-2030.
- Do not stop taking your topiramate without talking to your doctor.
- Contact your pharmacist or doctor to verify whether your supply is affected and discuss next steps.
The agency's original wording
Hazard
Failed dissolution specifications.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
11304 bottles
Manufactured in
9715 Key West Ave, N/A, Rockville, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0833-2026Want us to check the next one for you?
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