Dextroamphetamine Sulfate Tablets USP — Class II drug recall D-0825-2016
Terminated recall by Impax Laboratories, Inc., reported 2016-04-27, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0825-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Impax Laboratories, Inc., Middlesex, NJ, United States |
| Recall initiated | 2016-03-14 |
| Classified | 2016-04-21 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2018-02-09 |
| Distributed | Nationwide (US) |
| Quantity | 67,428 bottles |
| Reason classes | specification failure |
| NDC | 64720-0216-10 |
| Lot numbers | 03/17, 04/16, 05/16, 07/17, 09/16, 10/17, 11/16, 111013A, 111014, 111671, 111673, 111874, 111875, 111876, 112579, 112580, 113292, 113332, 113386, 113387, 113806, 113807 |
Product
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
Reason for recall
Failed Impurities/Degradation Specifications
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-0825-2016. 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.