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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.
- 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.
Distribution
Distributed nationwide across the United States.
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