The Recall Desk
Agency classClass IOur severity: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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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
Manufacturer
Nova Products, Inc.
Category
Drug — Supplement
Hazard

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 →

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