Teva Dextroamphetamine Saccharate — Class II drug recall D-1094-2014
Terminated recall by Teva Pharmaceuticals USA, reported 2014-03-12, distributed nationwide. CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine
| Recall number | D-1094-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2014-01-24 |
| Classified | 2014-02-28 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2014-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 9,796 tablets |
| Reason classes | cgmp, unapproved product |
| 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 | 10/16, 34017575A |
Product
Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.
Reason for recall
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
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-1094-2014. 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.