Severity
Critical
FDA Drug recall · Reported May 22, 2013
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfuncti…
The recall
Evol Nutrition issued this critical-severity FDA Drug recall — Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analo….
Sourced from official FDA Drug enforcement records. Verify recall #D-327-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-327-2013) was formally reported on May 22, 2013, with the manufacturer initiating the action on August 23, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Evol Nutrition is listed as the recalling firm, operating out of Kennesaw, GA. Federal records list the affected scope as 1000 blister packs (total both products).
The documented reason for this recall is: Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs. Distribution data in the federal record shows the product reached: Nationwide. 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.
Where this recall sits in its category — 14,048 drugs & medications recalls on record
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Severity
Critical
Affected scope
1000 blister packs (total both products)
Related Recalls
6
5 from same agency
Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-327-2013 |
| Date reported | May 22, 2013 |
| Date initiated | August 23, 2012 |
| Recalling firm | Evol Nutrition |
| Firm location | Kennesaw, GA |
| Affected scope | 1000 blister packs (total both products) |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
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Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported May 22, 2013.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).