Trokendi Xr Capsule, Extended Release
FDA Recall NDC 17772-101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Trokendi Xr (NDC 17772-101). A significant event, classified as Class III, was initiated on Jul 06, 2026 by Supernus Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Dissolution Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Dissolution Specifications
Jul 06, 2026
Jul 29, 2026
15,853 bottles
Recall Profile & Regulatory Data
Event ID
99375
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Supernus Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
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.
Batch or Lot Expiration Information
Lot# 2075801, Exp Date: 31-Oct-2029.
Affected Packages Involved in this Recall
17772-102-70Product
17772-102-01Product
17772-102-30Product
17772-102-15Product
17772-102-10Product
17772-102-12Product
17772-102-07Product
17772-103-70Product
17772-103-01Product
17772-103-30Product
17772-103-15Product
17772-103-10Product
17772-103-12Product
17772-103-07Product
17772-104-70Product
17772-104-01Product
17772-104-30Product
17772-104-15Product
17772-104-12Product
17772-104-10Product
17772-104-07Product
17772-101-70Product
17772-101-01Product
17772-101-30Product
17772-101-15Product
17772-101-10Product
17772-101-12Product
17772-101-07Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
490 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30
Batch or Lot Expiration Information
Lot# 1741214
Affected Packages Involved in this Recall
17772-102-70Product
17772-102-01Product
17772-102-30Product
17772-102-15Product
17772-102-10Product
17772-102-12Product
17772-102-07Product
17772-103-70Product
17772-103-01Product
17772-103-30Product
17772-103-15Product
17772-103-10Product
17772-103-12Product
17772-103-07Product
17772-104-70Product
17772-104-01Product
17772-104-30Product
17772-104-15Product
17772-104-12Product
17772-104-10Product
17772-104-07Product
17772-101-70Product
17772-101-01Product
17772-101-30Product
17772-101-15Product
17772-101-10Product
17772-101-12Product
17772-101-07Product
Class II Terminated
Superpotent Drug: Failure of assay specifications in the capsule.
Jul 12, 2016
Oct 26, 2016
17,128 (30-count blister packs)
Recall Profile & Regulatory Data
Event ID
74988
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Supernus Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 26, 2019
Product Description
Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15
Batch or Lot Expiration Information
Lot# 426636, Exp 4/22/18
Affected Packages Involved in this Recall
17772-102-70Product
17772-102-01Product
17772-102-30Product
17772-102-15Product
17772-102-10Product
17772-102-12Product
17772-102-07Product
17772-103-70Product
17772-103-01Product
17772-103-30Product
17772-103-15Product
17772-103-10Product
17772-103-12Product
17772-103-07Product
17772-104-70Product
17772-104-01Product
17772-104-30Product
17772-104-15Product
17772-104-12Product
17772-104-10Product
17772-104-07Product
17772-101-70Product
17772-101-01Product
17772-101-30Product
17772-101-15Product
17772-101-10Product
17772-101-12Product
17772-101-07Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
