FDA Drug recall D-1602-2014
XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789
- FDA Drug
- Class I
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class I recall of XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789 by Nova Products, citing marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1602-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-03-28 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Nova Products |
| Distribution | US |
Product
XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789
Reason
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Identifiers
| code_info | lot# 131110GL |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1602-2014%22
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