Xzen 1200 — Class I drug recall D-1600-2014
Terminated recall by Nova Products, Inc., reported 2014-09-24, distributed nationwide. Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xze
| Recall number | D-1600-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nova Products, Inc., Aston, PA, United States |
| Recall initiated | 2014-03-28 |
| Classified | 2014-09-18 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2015-08-06 |
| Distributed | Nationwide (US) |
| Reason classes | undeclared allergen, unapproved product |
| Lot numbers | 13051012 |
Product
Xzen 1200, 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 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
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-1600-2014. 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.