The Recall Desk
CriticalFDA (Drugs)·D-1334-2014·Announced 2014-05-28

XZONE GOLD Dietary Supplement Recalled for Undeclared Sildenafil and Tadalafil

Schindele Enterprises is recalling XZONE GOLD dietary supplements because they contain undeclared sildenafil, an analogue of sildenafil, and/or 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

Schindele Enterprises dba Midwest Wholesale is recalling XZONE GOLD, 1 capsule blister 750 mg, distributed by XZONE in Orlando, FL. The recall involves 175 blister packs with Lot # 130710GL and an expiration date of 07/31/2018.

The product is being recalled because it was marketed without an approved NDA/ANDA and contains undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. These ingredients are not declared on the product label.

The affected products were distributed to Pennsylvania, Illinois, Texas, Iowa, Georgia, Connecticut, Florida, California, Louisiana, New York, Maryland, Nevada, and Wisconsin. Consumers should stop using the product and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.
Affected units
175

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 (2)

  • Lot # 130710GL
  • Exp. 07/31/2018

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 7 recalled by Schindele Enterprises dba Midwest Wholesale 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 7 products in this recall →

Same manufacturer · Schindele Enterprises dba Midwest Wholesale

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