Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported September 24, 2014
XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undec…
Nova Products, Inc. recalled XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA … - a critical-severity action.
XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA … was recalled by Nova Products, Inc. in September 24, 2014. Reason: Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling X…. Check the official notice for the remedy. Verify recall #D-1598-2014 with the FDA Drug before acting.
The recall
Nova Products, Inc. issued this critical-severity FDA Drug recall-Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling X….
- Critical
- severity level
- Class I
- classification
- September 24, 2014
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1598-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1598-2014) was formally reported on September 24, 2014, with the manufacturer initiating the action on March 28, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Nova Products, Inc. is listed as the recalling firm, operating out of Aston, PA. Federal records list the affected scope as Unknown.
The documented reason for this recall is: Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafi… Distribution data in the federal record shows the product reached: Nationwide to retailers and distributors. 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 - 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.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products 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
Unknown
Related Recalls
6
0 from same agency
Product description
XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012
Reason for recall
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-1598-2014 |
| Date reported | September 24, 2014 |
| Date initiated | March 28, 2014 |
| Recalling firm | Nova Products, Inc. |
| Firm location | Aston, PA |
| Affected scope | Unknown |
| Distribution | Nationwide to retailers and distributors |
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-1598-2014) 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? ▼
XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012. Recalled by Nova Products, Inc.. Units affected: Unknown.
Why was this product recalled? ▼
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 24, 2014. Severity: Critical. Recall number: D-1598-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide to retailers and distributors.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1598-2014) 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.
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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 September 24, 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.