Dexedrine¿ — Class II drug recall D-385-2014
Terminated recall by Amedra Pharmaceuticals LLC, reported 2014-01-01, distributed nationwide. Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stab
| Recall number | D-385-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amedra Pharmaceuticals LLC, Horsham, PA, United States |
| Recall initiated | 2013-10-07 |
| Classified | 2013-12-23 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2014-10-07 |
| Distributed | Nationwide (US) |
| Quantity | 10,992 bottles |
| Reason classes | specification failure |
| NDC | 52054-0514-09 |
| Lot numbers | 01/14, 243459 |
Product
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
Reason for recall
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-385-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.