DEXTROAMPHETAMINE SACCHARATE — Class II drug recall D-0050-2015
Terminated recall by Teva Pharmaceuticals USA, reported 2014-11-05, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
| Recall number | D-0050-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2014-10-08 |
| Classified | 2014-10-27 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-09-21 |
| Distributed | Nationwide (US) |
| Quantity | 19,545 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 | 34016373A, 34016377A |
| Expiration dates | 2016-07 |
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for unknown 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-0050-2015. 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.