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.
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
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.
- Manufacturer
- Schindele Enterprises dba Midwest Wholesale
- Category
- Drug — Dietary Supplement
- 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
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 →Related recalls
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