The Recall Desk
CriticalFDA (Drugs)·D-1598-2014·Announced 2014-09-24

XZEN GOLD Recalled for Undeclared Erectile Dysfunction Drug Ingredients

Nova Products, Inc. is voluntarily recalling XZEN GOLD capsules because FDA testing found undeclared sildenafil and tadalafil.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric.

Plain-English summary

Nova Products, Inc. of Aston, Pennsylvania, is voluntarily recalling XZEN GOLD, 750 mg, six capsules per bottle. The product is distributed by XZEN in Los Angeles, California, and was distributed nationwide to retailers and distributors.

The recall is being conducted because FDA laboratory analysis determined that the capsules contain undeclared amounts of sildenafil and tadalafil. These are active ingredients of FDA-approved drugs used to treat erectile dysfunction. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Consumers who have purchased XZEN GOLD, specifically Lot# 130310GL, should stop using the product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot# 130310GL

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Nova Products, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →