FDAFDA recall D-0758-2026 · Jul 29, 2026
Supernus Pharmaceuticals, Inc.: Trokendi XR recall
Recall found
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.
Reason for recall
Failed Dissolution Specifications
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class III: use of or exposure to the product is not likely to cause health problems.
- Status
- Ongoing
- Codes, lots and dates
- Lot # 2075801, Exp Date: 31-Oct-2029.
- Quantity
- 15,853 bottles
- Distribution
- US Nationwide.
- Recalling firm
- Supernus Pharmaceuticals, Inc., Rockville, MD
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-06
Source: openFDA enforcement record D-0758-2026 · search recall number D-0758-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 31, 2026, 6:32 AM EDT. The agency notice is the final word.