The Recall Desk
SevereFDA (Drugs)·D-1602-2014·Announced 2014-09-24

XZONE GOLD recalled for undeclared erectile dysfunction drug ingredients

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD, 750 mg, one capsule blister pack. The product was distributed nationwide to retailers and distributors by XZONE in Orlando, Florida. The specific lot number is 131110GL.

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 this product should stop using it and contact the distributor or retailer for further instructions.

The recalled product

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

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# 131110GL

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 →