# FDA recall D-1075-2014

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2013-12-18.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1075-2014
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-12-18
- **Report date:** 2014-02-12
- **Termination date:** 2014-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horsham, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1075-2014

## Citation

> AI Analytics. FDA recall D-1075-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1075-2014. Source: US FDA. Licensed CC0.

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