Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
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Contact the company
📍Recalling firmHyobin LLC455 S Pleasant Ave · Ridgewood, NJ 07450-5413
✎ GovInfoNow plain-language explainer
Hyobin LLC is recalling PremierZen Black 5000, a product marketed as a dietary supplement but found to contain tadalafil, an ingredient in prescription erectile dysfunction medications. The FDA determined the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Because it contains an unapproved drug ingredient, it poses health risks not associated with standard supplements. Read more at govinfonow.com/recall/36218-premierzen-black-5000-recall-unapproved-drug-with-tadalafil.
“PremierZen Black 5000 Recall: Unapproved Drug with Tadalafil.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36218-premierzen-black-5000-recall-unapproved-drug-with-tadalafil. Based on FDA recall #D-0382-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0382-2021%22&limit=1).
The Food and Drug Administration announced on April 6, 2021, that Hyobin LLC is recalling PremierZen Black 5000 Capsules. The product was marketed without an approved New Drug Application or Abbreviated New Drug Application. FDA analysis detected the presence of tadalafil in the capsules.
How to tell if you have it
Brand: PremierZen
Product: PremierZen Black 5000 Capsules
Packaging: Cardboard blisters containing one capsule per card
Distributor: Yolo Studio, Cliffside Park, NJ
Quantity: 500 cards
Distribution: USA Nationwide
The hazard
The FDA stated that the product was marketed without an approved New Drug Application or Abbreviated New Drug Application. Analysis results obtained by the agency found the presence of tadalafil in the capsules.
Context
GovInfoNow's records show other recent recalls of similar products include StuffbyNainax MR 7 SUPER 700000 Capsules (2025-12-15) and Shoolin Pharma Chem Tadalafil 500g Recall (2026-08-03). SUN PHARMACEUTICAL Xyvona 3mg Tablets Recall occurred on 2026-05-22 following an FDA denial of marketing.
How to tell if you have this one
Look for PremierZen Black 5000 packaged in cardboard blisters containing one capsule per card. The product was distributed nationwide by Yolo Studio of Cliffside Park, NJ. All lots are included in this recall.
Brand
PremierZen
Category
Drug
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
USA Nationwide
Recall number
Product, codes & lots
Quantity
D-0381-2021
PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ; all lots
500 cards
D-0382-2021
PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ; all lots
500 cards
D-0383-2021
Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ; all lots
300 cards
Based on the official FDA remedy
What to do — step by step
Stop using the product
Cease consumption of PremierZen Black 5000 immediately due to the presence of unapproved tadalafil.
Dispose of the product
Discard any remaining capsules or return them as instructed by the distributor, though specific disposal instructions are not provided in this record.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0382-2021 (April 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0382-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.