MaXtremeZEN capsules — Class I drug recall D-1046-2014
Terminated recall by SS Wholesale Inc. dba Jobbers Wholesale, reported 2014-02-05, distributed in CA. Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplemen
| Recall number | D-1046-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SS Wholesale Inc. dba Jobbers Wholesale, Paramount, CA, United States |
| Recall initiated | 2013-11-18 |
| Classified | 2014-01-30 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2014-05-09 |
| Distributed | CA |
| Quantity | 2,395 blister |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00610079524682 |
| Lot numbers | 12/16, JBP-L-1270-70 |
Product
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1046-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.