The Recall Desk
CriticalFDA (Drugs)·D-1599-2014·Announced 2014-09-24

XZEN Platinum Recalled for Undeclared Erectile Dysfunction Drug Ingredients

Nova Products, Inc. is voluntarily recalling XZEN Platinum capsules because FDA analysis 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 according to the rubric.

Plain-English summary

Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN Platinum, 750 mg, 1 capsule per blister pack. The product is distributed by XZEN in Los Angeles, California, and was marketed nationwide to retailers and distributors.

The recall was initiated because FDA laboratory analysis determined that the capsules contain undeclared amounts of sildenafil and tadalafil. These are active ingredients used in FDA-approved drugs 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 Platinum, specifically Lot# 130520PL, should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
XZEN PLATINUM, 750 mg, 1 capsule per blister pack, 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# 130520PL

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 →