FDA Drugs recall ·
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules… recall
- Recall number
- D-0758-2026
- Date
- (initiated July 6, 2026)
- Company / brand
- Supernus Pharmaceuticals, Inc.
9715 Key West Ave, Rockville, MD, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 15,853 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.
Why was it recalled?
Failed Dissolution Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 2075801, Exp Date: 31-Oct-2029.
Distribution
US Nationwide.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0758-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.