Trokendi XR 50 mg Capsules Recall Over Failed Dissolution Specifications
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Supernus Pharmaceuticals, Inc. is recalling 11,304 bottles of Trokendi XR (topiramate) extended-release capsules due to failed dissolution specifications.
FDA recall: what the record actually shows
This notice was issued by FDA on September 14, 2026 and geographically references United States. The FDA classifies this as a Class III recall, with the stated reason "Failed dissolution specifications.", distributed us nationwide.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.
The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, drugs.
What Happened
Supernus Pharmaceuticals, Inc. initiated a voluntary recall of Trokendi XR due to failed dissolution specifications.
Which Products Are Affected
Trokendi XR (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, NDC 17772-102-30. Lot# 2145283, Exp Date: 31-Mar-2030. 11,304 bottles distributed nationwide in the United States.
What You Should Do
No specific consumer actions are detailed in the recall notice.
Why This Matters
This is a Class III recall involving a prescription drug that failed quality specifications.
Source
FDA recall number D-0833-2026, report date 2026-09-09.
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
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Similar body length
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Similar severity timing
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