XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012
FDA Drug Recall #D-1598-2014 — Class I — March 28, 2014
Recall Summary
| Recall Number | D-1598-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | March 28, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nova Products, Inc. |
| Location | Aston, PA |
| Product Type | Drugs |
| Quantity | Unknown |
Product Description
XZEN GOLD,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 GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Distribution Pattern
Nationwide to retailers and distributors
Lot / Code Information
Lot# 130310GL
Other Recalls from Nova Products, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1596-2014 | Class I | AFRICAN BLACK ANT, 2800 mg, 6 capsules per box,... | Mar 28, 2014 |
| D-1597-2014 | Class I | Black Ant, 4600 mg, four capsules per box, , Ma... | Mar 28, 2014 |
| D-1601-2014 | Class I | Xzone 1200, 750 mg, one capsule per blister pa... | Mar 28, 2014 |
| D-1599-2014 | Class I | XZEN PLATINUM, 750 mg, 1 capsule per blister pa... | Mar 28, 2014 |
| D-1602-2014 | Class I | XZONE GOLD, 750 mg, one capsule blister pack, ... | Mar 28, 2014 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.