Medications & Supplements/Dietary Supplements

Hyobin LLC: PremierZen and SupremeZen Supplements Recalled for Undeclared Tadalafil

Agency Publication Date: May 14, 2021

Summary

Hyobin LLC is recalling approximately 1,300 cardboard blister cards of PremierZen Extreme 3000, PremierZen Black 5000, and Triple SupremeZen Plus 3500 because FDA analysis found they contain tadalafil. Tadalafil is an active ingredient in FDA-approved prescription drugs for erectile dysfunction; however, these supplements are being marketed without approved drug applications, making them unapproved new drugs. These products were distributed nationwide by Yolo Studio in single-capsule cardboard blisters.

Risk

Tadalafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous or life-threatening levels. This is particularly concerning for consumers with diabetes, high blood pressure, high cholesterol, or heart disease who often take prescription nitrates.

What You Should Do

Check your products to see if you have PremierZen Extreme 3000, PremierZen Black 5000, or Triple SupremeZen Plus 3500, which are packaged in cardboard blisters containing one capsule per card.
Verify if your product was distributed by Yolo Studio (Cliffside Park, NJ); all lots of these specific brands are included in this recall.
Stop using these products immediately and either safely dispose of them or prepare to return them.
Contact your healthcare provider or pharmacist for guidance if you have used these products and have concerns about your health.
Return any unused product to the place of purchase for a refund and contact Hyobin LLC at their Ridgewood, New Jersey office for further instructions.
For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Full refund upon return of unused product

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

Affected Products

Product: PremierZen Extreme 3000 (1 capsule card)

Model:

D-0381-2021

Lot Numbers:

all lots

Product: PremierZen Black 5000 (1 capsule card)

Model:

D-0382-2021

Lot Numbers:

all lots

Product: Triple SupremeZen Plus 3500 (1 capsule card)

Model:

D-0383-2021

Lot Numbers:

all lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87711

Status: Active

Manufacturer: Hyobin LLC

Sold By: Yolo Studio

Manufactured In: United States

Units Affected: 3 products (500 cards; 500 cards; 300 cards)

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 · 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.

Summary

Risk

What You Should Do

Check your products to see if you have PremierZen Extreme 3000, PremierZen Black 5000, or Triple SupremeZen Plus 3500, which are packaged in cardboard blisters containing one capsule per card.

Verify if your product was distributed by Yolo Studio (Cliffside Park, NJ); all lots of these specific brands are included in this recall.

Stop using these products immediately and either safely dispose of them or prepare to return them.

Contact your healthcare provider or pharmacist for guidance if you have used these products and have concerns about your health.

Return any unused product to the place of purchase for a refund and contact Hyobin LLC at their Ridgewood, New Jersey office for further instructions.

For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.