Supernus Recalls Trokendi XR Topiramate Capsules for Dissolution Failure
Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) extended-release capsules because they failed dissolution specifications. The recall covers 11,304 bottles distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Supernus Pharmaceuticals, Inc. is recalling Trokendi XR (topiramate) extended-release capsules, 50 mg, 30 capsules per bottle. The recall is due to the product failing dissolution specifications. The affected product is identified by Lot # 2145283 and has an expiration date of 31-Mar-2030.
The recall involves 11,304 bottles of the medication, which were distributed nationwide in the United States. The product is a prescription-only medication manufactured by Catalent Pharma Solutions for Supernus Pharmaceuticals.
Consumers and healthcare providers should stop using the affected Trokendi XR capsules and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- TROKENDI XR (TOPIRAMATE)
- Brand
- TROKENDI XR
- Manufacturer
- Supernus Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 11,304
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 2145283
- Exp Date: 31-Mar-2030.
UPCs (4)
- 0317772101300
- 0317772102307
- 0317772104301
- 0317772103304
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · TROKENDI XR
- LowSupernus Recalls Trokendi XR Capsules for Failed Dissolution Specifications
FDA (Drugs) · 2026-07-29
- SevereCardinal Health Recalls Trokendi XR Capsules Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- HighSupernus Recalls Trokendi XR Capsules Due to Assay Failure
FDA (Drugs) · 2016-10-26
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