CLASS I Drug recall · Reported 5 Feb 2014 · FDA Enforcement Report
eXtenZone capsules recalled by SS Wholesale
SS Wholesale is recalling eXtenZone capsules per, distributed in California. The recall was initiated on 18 Nov 2013 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-1047-2014
- FDA event ID
- 66840
- Recalling firm
- SS Wholesale, Paramount, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Nov 2013
- FDA classified
- 30 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 18 Nov 2013 | Recall initiated by company | |
| 30 Jan 2014 | Classified by FDA | +73 days |
| 5 Feb 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: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b
Product as listed by the FDA
eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6.
Where it was distributed
CA
Questions about this recall
Why was it recalled?
Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b
Which lots are affected?
Lot #: KWAKPMC03050517, Exp 12/16
Where was it sold?
CA
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
2 other products · FDA event 66840| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | MaXtremeZEN capsules recalled by SS Wholesale | SS Wholesale | Labeling Errors | CA | |
| CLASS I | Rhino(Spanish & English Labeling) recalled by SS Wholesale | SS Wholesale | Labeling Errors | CA |
More recalls from SS Wholesale
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Rhino(Spanish & English Labeling) recalled by SS Wholesale | SS Wholesale | Labeling Errors | CA |
| Drug | CLASS I | MaXtremeZEN capsules recalled by SS Wholesale | SS Wholesale | Labeling Errors | CA |