CLASS I Drug recall · Reported 16 Apr 2014 · FDA Enforcement Report
Vicerex A Powerful And Fast Acting Male Sexual Enhancer recalled
American Lifestyle.Com is recalling Vicerex A Powerful And Fast Acting Male Sexual Enhancer per, Dietary Supplement. The recall was initiated on 30 Apr 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1223-2014
- FDA event ID
- 65095
- Recalling firm
- American Lifestyle.Com, Pittsford, NY
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Apr 2013
- FDA classified
- 7 Apr 2014
- Reported
- 16 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
Timeline
| 30 Apr 2013 | Recall initiated by company | |
| 7 Apr 2014 | Classified by FDA | +342 days |
| 16 Apr 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.
Product as listed by the FDA
Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com.
Where it was distributed
Domestic distribution currently under Investigation; International distribution includes, but may not be limited to the following countries : Mexico, France, Brazil, Belgium, Denmark, Switzerland, Spain, Canada, Italy, Japan, Ireland, Venezuela, Oman.
Questions about this recall
Why was it recalled?
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.
Which lots are affected?
All lots, UPC 893490820087
Where was it sold?
Domestic distribution currently under Investigation; International distribution includes, but may not be limited to the following countries : Mexico, France, Brazil, Belgium, Denmark, Switzerland, Spain, Canada, Italy, Japan, Ireland, Venezuela, Oman.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 65095| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Black Ant, 4600 mg x Product recalled by American Lifestyle.Com | American Lifestyle.Com | Labeling Errors | NY |
More recalls from American Lifestyle.Com
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Black Ant, 4600 mg x Product recalled by American Lifestyle.Com | American Lifestyle.Com | Labeling Errors | NY |