# FDA recall D-1602-2014

> **Nova Products, Inc.** · Class I · drug recall initiated 2014-03-28.

## Product

XZONE GOLD,  750 mg, one capsule blister pack,  Distributed by: XZONE, Orlando, FL 32789

## Reason for recall

Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to  treat erectile dysfunction.

## Distribution

Nationwide to retailers and distributors

## Key facts

- **Recall number:** D-1602-2014
- **Recalling firm:** Nova Products, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-03-28
- **Report date:** 2014-09-24
- **Termination date:** 2015-08-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1602-2014

## Citation

> AI Analytics. FDA recall D-1602-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1602-2014. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*