Supernus Recalls Trokendi XR Capsules for Failed Dissolution Specifications
Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) capsules because they failed dissolution specifications. The recall covers 15,853 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Supernus Pharmaceuticals, Inc. is recalling Trokendi XR (topiramate) extended-release capsules, 25mg, due to failed dissolution specifications. The affected product is identified by Lot # 2075801 and has an expiration date of 31-Oct-2029. The product is manufactured by Catalent Pharma Solutions in Winchester, KY, and distributed by Supernus Pharmaceuticals in Rockville, MD.
A total of 15,853 bottles were distributed nationwide. The recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall number is D-0758-2026.
The recalled product
- Product
- TROKENDI XR (TOPIRAMATE)
- Brand
- TROKENDI XR
- Manufacturer
- Supernus Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 15,853
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 # 2075801
- Exp Date: 31-Oct-2029.
UPCs (4)
- 0317772101300
- 0317772102307
- 0317772104301
- 0317772103304
Distribution
Distributed nationwide across the United States.
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