FDA Drug recall D-0566-2016
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Ent…
- FDA Drug
- Class II
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class II recall of DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Ent… by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0566-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-12 |
| Published | 2016-01-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
Reason
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Identifiers
| upc | 305550972020 |
|---|---|
| ndc | 0555-0971-02 |
| ndc | 0555-0775-02 |
| ndc | 0555-0972-02 |
| ndc | 0555-0776-02 |
| ndc | 0555-0777-02 |
| ndc | 0555-0973-02 |
| ndc | 0555-0974-02 |
| code_info | Lot #: 34015516A, Exp 05/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0566-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.