The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1600-2014·Announced 2014-09-24

Nova Products Recalls Xzen 1200 Due to Undeclared Erectile Dysfunction Ingredients

Nova Products, Inc. is voluntarily recalling Xzen 1200 capsules because FDA analysis found undeclared sildenafil and tadalafil, active ingredients in erectile dysfunction drugs.

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 according to the rubric.

Plain-English summary

Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200, 750 mg, six capsules per bottle. The product is distributed by xzen in Los Angeles, California, and was marketed nationwide to retailers and distributors. The specific lot number is 13051012.

The recall was initiated 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 1200 should stop using the product and contact the recalling firm or their point of purchase for instructions on how to return the product or obtain a refund.

The recalled product

Product
Xzen 1200, 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# 13051012

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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