Hydralazine HCL Tablets — Class II drug recall D-1075-2014
Terminated recall by Teva Pharmaceuticals USA, reported 2014-02-12, distributed nationwide. Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification f
| Recall number | D-1075-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2013-12-18 |
| Classified | 2014-02-04 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 112,800 tablets |
| Reason classes | specification failure |
| NDC | 00182-0555-00, 00182-0555-89 |
| Lot numbers | 01/14, 6A201018VA |
Product
Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single blister).
Reason for recall
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
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-1075-2014. 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.