Supernus Trokendi XR topiramate capsules recalled for failed dissolution specifications
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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- Adults
Details
- Units affected
- 11304 bottles
- Illnesses reported
- None reported
- Manufactured in
- 9715 Key West Ave, N/A, Rockville, MD, United States
- Classification
- Class III
- Recall number
- D-0833-2026
In the FDA's words
- Description
- 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. Failed dissolution specifications. Lot# 2145283, Exp Date: 31-Mar-2030. Distribution: US Nationwide. Affected quantity: 11304 bottles
- Hazard
- Failed dissolution specifications.