Trokendi XR, topiramate extended-release capsules, 25mg, 30 Rx only, Manufactured by… recall
FDA recall D-0758-2026 · initiated Jul 6, 2026
Supernus Pharmaceuticals, Inc. recalled Trokendi XR, topiramate extended-release capsules, 25mg, 30 Rx only… in Jul 2026 — an FDA Class III recall (D-0758-2026) because Failed Dissolution Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 15,853 bottles
Details
- 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.
- Recalling company
- Supernus Pharms
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Jul 6, 2026
- FDA report date
- Jul 29, 2026
Frequently asked
- Was Trokendi XR, topiramate extended-release capsules, 25mg, 30 Rx only… recalled?
- Supernus Pharmaceuticals, Inc. recalled Trokendi XR, topiramate extended-release capsules, 25mg, 30 Rx only… in Jul 2026 — an FDA Class III recall (D-0758-2026) because Failed Dissolution Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Trokendi XR, topiramate extended-release capsules, 25mg, 30 Rx only… recalled?
- Per the FDA enforcement record, the reason for recall D-0758-2026 was: Failed Dissolution Specifications
- Is a recalled Trokendi XR, topiramate extended-release capsules, 25mg, 30 Rx only… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Trokendi XR, topiramate extended-release capsules, 25mg, 30 Rx only… are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # 2075801, Exp Date: 31-Oct-2029.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0758-2026.