Dextroamphetamine Saccharate — Class III drug recall D-190-2013
Terminated recall by Actavis Elizabeth LLC, reported 2013-03-13, distributed nationwide. Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissoluti
| Recall number | D-190-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Elizabeth LLC, Elizabeth, NJ, United States |
| Recall initiated | 2013-02-13 |
| Classified | 2013-03-07 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2014-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 9,264 bottles |
| Reason classes | specification failure |
| NDC | 00228-3059, 00228-3059-11, 00228-3060, 00228-3060-11, 00228-3061, 00228-3061-11, 00228-3062, 00228-3062-11, 00228-3063, 00228-3063-11, 00228-3064, 00228-3064-11 |
| Lot numbers | 50077231 |
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
Reason for recall
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
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-190-2013. 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.