Dextroamphetamine Saccharate — Class II drug recall D-0816-2016
Terminated recall by Actavis Elizabeth LLC, reported 2016-04-13, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification for impurities.
| Recall number | D-0816-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Elizabeth LLC, Elizabeth, NJ, United States |
| Recall initiated | 2016-02-16 |
| Classified | 2016-04-07 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2017-09-22 |
| Distributed | Nationwide (US) |
| Quantity | 38,507 bottles |
| Reason classes | specification failure |
| NDC | 45963-0743-11 |
| Lot numbers | 0953C151, 1728D151, 3/17, 3205G152, 5245M141, 6/16, 8/16LOT, 9/16 |
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
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-0816-2016. 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.