Why it was recalled
Failed Dissolution Specifications
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 2075801, Exp Date: 31-Oct-2029.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0758-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jul 6, 2026
- FDA report date
- Jul 29, 2026
- Quantity
- 15,853 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Supernus Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0758-2026, exactly as published.
Show all FDA fields
- City
- Rockville
- State
- MD
- Status
- Ongoing
- Country
- United States
- Event ID
- 99375
- Address
- 9715 Key West Ave
- Code information
- Lot # 2075801, Exp Date: 31-Oct-2029.
- Postal code
- 20850-3900
- Report date
- Jul 29, 2026
- Product type
- Drugs
- Recall number
- D-0758-2026
- Classification
- Class III
- Recalling firm
- Supernus Pharmaceuticals, Inc.
- Product quantity
- 15,853 bottles
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Jul 6, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 11, 2026