CLASS I Drug recall · Reported 24 Sep 2014 · FDA Enforcement Report
Xzen Platinum, 750 mg recalled by Nova Products
Nova Products is recalling Xzen Platinum, 750 mg per, distributed nationwide in the US. The recall was initiated on 28 Mar 2014 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-1599-2014
- FDA event ID
- 67860
- Recalling firm
- Nova Products, Aston, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 28 Mar 2014
- FDA classified
- 18 Sep 2014
- Reported
- 24 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 28 Mar 2014 | Recall initiated by company | |
| 18 Sep 2014 | Classified by FDA | +174 days |
| 24 Sep 2014 | Published in enforcement report | +6 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: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Product as listed by the FDA
XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012
Where it was distributed
Nationwide to retailers and distributors
Questions about this recall
Why was it recalled?
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM 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 lots are affected?
Lot# 130520PL
Where was it sold?
Nationwide to retailers and distributors
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
7 other products · FDA event 67860This product is part of a recall event; the main page for the event is African Black Ant, 2800 mg recalled by Nova Products.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | African Black Ant, 2800 mg recalled by Nova Products | Nova Products | Labeling Errors | Nationwide | |
| CLASS I | Black Ant, 4600 mg, four capsules recalled by Nova Products | Nova Products | Labeling Errors | Nationwide | |
| CLASS I | Xzone 1200, 750 mg, one capsule recalled by Nova Products | Nova Products | Labeling Errors | Nationwide | |
| CLASS I | Xzone Gold, 750 mg, one capsule recalled by Nova Products | Nova Products | Labeling Errors | Nationwide | |
| CLASS I | Xzen Gold,750 mg, six capsules recalled by Nova Products | Nova Products | Labeling Errors | Nationwide | |
| CLASS I | Xzen 1200, 750 mg, six capsules recalled by Nova Products | Nova Products | Labeling Errors | Nationwide | |
| CLASS I | Mojo Risen ,670 mg recalled by Nova Products | Nova Products | Labeling Errors | Nationwide |
More recalls from Nova Products
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Mojo Risen ,670 mg recalled by Nova Products | Nova Products | Labeling Errors | Nationwide |
| Drug | CLASS I | Xzen 1200, 750 mg, six capsules recalled by Nova Products | Nova Products | Labeling Errors | Nationwide |
| Drug | CLASS I | Xzen Gold,750 mg, six capsules recalled by Nova Products | Nova Products | Labeling Errors | Nationwide |
| Drug | CLASS I | Xzone Gold, 750 mg, one capsule recalled by Nova Products | Nova Products | Labeling Errors | Nationwide |
| Drug | CLASS I | Xzone 1200, 750 mg, one capsule recalled by Nova Products | Nova Products | Labeling Errors | Nationwide |
Other Xzen Platinum recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Xzen Platinum, 750 mg recalled by Schindele Enterprises | Schindele Enterprises | Labeling Errors | 13 states |