DEXTROAMPHETAMINE SACCHARATE — Class II drug recall D-0566-2016
Terminated recall by Teva Pharmaceuticals USA, reported 2016-01-20, distributed nationwide. Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stab
| Recall number | D-0566-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2015-11-12 |
| Classified | 2016-01-11 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-11-01 |
| Distributed | Nationwide (US) |
| Quantity | 9,717 bottles |
| Reason classes | specification failure |
| NDC | 00555-0775, 00555-0775-02, 00555-0776, 00555-0776-02, 00555-0777, 00555-0777-02, 00555-0971, 00555-0971-02, 00555-0972, 00555-0972-02, 00555-0973, 00555-0973-02, 00555-0974, 00555-0974-02 |
| Lot numbers | 05/16, 34015516A |
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 for recall
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
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-0566-2016. 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.