Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg Recalled by Amedra Pharmaceuticals LLC Due to Failed Dissolution Specifications: Out of Specification (OOS) test...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Amedra Pharmaceuticals LLC directly.
Affected Products
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
Quantity: 10,992 bottles
Why Was This Recalled?
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Amedra Pharmaceuticals LLC
Amedra Pharmaceuticals LLC has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report