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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Dietary Supplements

PrimeZEN Black 6000 Capsules Recalled for Undeclared Sildenafil and Tadalafil

Agency Publication Date: March 1, 2023
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Summary

Volt Candy Wholesale Club is recalling approximately 432 capsules of PrimeZEN Black 6000 (2000mg), marketed as a male sexual performance enhancement supplement. The FDA found the product contains undeclared sildenafil and tadalafil, the active ingredients in FDA-approved prescription drugs for erectile dysfunction. These ingredients were not listed on the label, making this an unapproved drug. No incidents or injuries have been reported to date.

Risk

Undeclared sildenafil and tadalafil can interact with nitrates found in some prescription medications, such as nitroglycerin, and may lower blood pressure to dangerous levels. This poses a significant health risk to individuals with heart disease, diabetes, high blood pressure, or high cholesterol who frequently take nitrates.

What You Should Do

  1. The recalled products are PrimeZEN Black 6000 capsules (2000mg) sold in 1-count blister cards with UPC 728175521891, lot number NPINPB 1003, and an expiration date of 08/16/2025.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions or to report a complaint.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: PrimeZEN Black 6000 Capsule (2000mg)
Variants: 1-count blister card
UPC Codes:
728175521891
Lot Numbers:
NPINPB 1003 (Exp 08/16/2025)

Distributed by: Prime Premier Group, Los Angeles, CA 90006

Product Images

Front of Package, PrimeZEN Black 6000

Front of Package, PrimeZEN Black 6000

Back of Package, PrimeZEN Black 6000

Back of Package, PrimeZEN Black 6000

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91711
Status: Resolved
Manufacturer: Volt Candy Wholesale Club
Sold By: Volt Candy Wholesale Club; Prime Premier Group
Manufactured In: United States
Units Affected: 432 capsules
Distributed To: Nationwide
Agency Last Updated: March 9, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.