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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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High RiskFDA Drug
Medications & Supplements/Dietary Supplements

Namoo Enterprise LLC: PremierZen Black 5000 Recalled for Presence of Tadalafil and Sildenafil

Agency Publication Date: April 26, 2021
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Summary

Namoo Enterprise LLC is recalling all lots of PremierZen Black 5000 (tadalafil and sildenafil) capsules because FDA analysis found they contain undeclared drug ingredients. These capsules are marketed as dietary supplements but contain hidden prescription drugs normally used for erectile dysfunction. The product was sold nationwide in single-capsule cards and 24-capsule boxes, distributed by New Premier Group. Consumers should stop using this product immediately and contact their healthcare provider or pharmacist, as these hidden ingredients can cause dangerous drops in blood pressure.

Risk

The undeclared tadalafil and sildenafil can interact with nitrates found in some prescription drugs (such as nitroglycerin), causing blood pressure to drop to unsafe levels. This pose a significant threat to consumers with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates.

What You Should Do

  1. Identify the product by checking your packaging for 'PremierZen Black 5000' capsules with UPC 7 2817542189 4.
  2. Check the distribution information on the label; affected products were distributed by New Premier Group, Los Angeles, CA 90006.
  3. Look for the lot and expiration information; this recall includes all lots currently within their expiration date.
  4. Stop using the product immediately and contact your healthcare provider or pharmacist if you have experienced any health problems while taking this supplement.
  5. Return any unused product to the place of purchase for a refund and contact Namoo Enterprise LLC for further instructions regarding the disposal or return of the items.
  6. For additional questions or to report a related health issue, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box
UPC Codes:
728175421894
Lot Numbers:
All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87609
Status: Resolved
Manufacturer: Namoo Enterprise LLC
Sold By: New Premier Group
Manufactured In: United States
Distributed To: Nationwide

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 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.