US Drug Recall Register
Class I · High risk Terminated Initiated Mar 28, 2014 (12 years ago)

Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.

What was recalled

Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012

Recalling firm
Nova Products, Inc.
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1600-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.