Dextroamphetamine Sulfate Extended-Release Capsules — Class II drug recall D-0395-2015
Terminated recall by Actavis Elizabeth LLC, reported 2015-03-11, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0395-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Elizabeth LLC, Elizabeth, NJ, United States |
| Recall initiated | 2015-02-10 |
| Classified | 2015-02-27 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2015-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 42 bottles |
| Reason classes | specification failure |
| NDC | 45963-0303, 45963-0303-09, 45963-0304, 45963-0304-09, 45963-0305, 45963-0305-09 |
| Lot numbers | 07/15, 2020E141 |
Product
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
Reason for recall
Failed Dissolution 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-0395-2015. 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.