Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported April 16, 2014
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).
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…
American Lifestyle.Com recalled Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on … - a critical-severity action.
Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on … was recalled by American Lifestyle.Com in April 16, 2014. Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex pr…. Check the official notice for the remedy. Verify recall #D-1224-2014 with the FDA Drug before acting.
The recall
American Lifestyle.Com issued this critical-severity FDA Drug recall-Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex pr….
- Critical
- severity level
- Class I
- classification
- April 16, 2014
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1224-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1224-2014) was formally reported on April 16, 2014, with the manufacturer initiating the action on April 30, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. American Lifestyle.Com is listed as the recalling firm, operating out of Pittsford, NY. Federal records list the affected scope as 3 boxes distributed domestically & 4 boxes distributed internationally to consumers..
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3 boxes distributed domestically & 4 boxes distributed internationally to consumers.
Related Recalls
6
5 from same agency
Product description
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).
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-1224-2014 |
| Date reported | April 16, 2014 |
| Date initiated | April 30, 2013 |
| Recalling firm | American Lifestyle.Com |
| Firm location | Pittsford, NY |
| Affected scope | 3 boxes distributed domestically & 4 boxes distributed internationally to consumers. |
| Distribution | 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, Vene… |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1224-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by American Lifestyle.Com. Units affected: 3 boxes distributed domestically & 4 boxes distributed internationally to consumers..
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on April 16, 2014. Severity: Critical. Recall number: D-1224-2014.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1224-2014) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 16, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.