CLASS I Drug recall · Reported 16 Apr 2014 · FDA Enforcement Report

Black Ant, 4600 mg x Product recalled by American Lifestyle.Com

American Lifestyle.Com is recalling Black Ant, 4600 mg x Product is. The recall was initiated on 30 Apr 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll lots, UPC 4026666142546.

Quantity recalled3 boxes distributed domestically & 4 boxes distributed internationally to consumers.

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-1224-2014
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

Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC 4026666142546 (product numbers may possibly vary for same product identification and same product packaging).

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?

Which lots are affected?

All lots, UPC 4026666142546.

Where was it sold?

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

This product is part of a recall event; the main page for the event is Vicerex A Powerful And Fast Acting Male Sexual Enhancer recalled.

Reported	Class	Recall	Company	Reason	Where
16 Apr 2014	CLASS I	Vicerex A Powerful And Fast Acting Male Sexual Enhancer recalled	American Lifestyle.Com	Labeling Errors	NY

More recalls from American Lifestyle.Com

All 2

Reported	Class	Recall	Company	Reason	Where
16 Apr 2014Drug	CLASS I	Vicerex A Powerful And Fast Acting Male Sexual Enhancer recalled	American Lifestyle.Com	Labeling Errors	NY

Other Black Ant recalls

All 4

Reported	Class	Recall	Company	Reason	Where
7 Feb 2018Drug	CLASS II	Black Ant capsules, 4600mg, labeling is in foreign language recalled	A&H Focal	Hidden Drug Ingredients	NJ, NY
8 Oct 2014Drug	CLASS I	Black Ant, 2800 mg, four capsules recalled by Eugene Oregon	Eugene Oregon	Labeling Errors	11 states
24 Sep 2014Drug	CLASS I	Black Ant, 4600 mg, four capsules recalled by Nova Products	Nova Products	Labeling Errors	Nationwide