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.
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 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
- Manufacturer
- Nova Products, Inc.
- Category
- Drug — Supplement
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 →Related recalls
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