Hyobin LLC recalls PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio,
Hyobin LLC recalls PremierZen Black 5000 capsules due to FDA finding tadalafil without approved NDA/ANDA. All lots affected; consumers should check for cardboard blister packaging.
Recall notice
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Contact the company & request your remedy
What happened, in plain English
Hyobin LLC is recalling all PremierZen Black 5000 capsules because the FDA found tadalafil (an unapproved drug) in them. This poses a risk of serious health effects since the product was marketed without proper FDA approval. Read more at govinfonow.com/recall/36218-hyobin-premierzen-black-50-fda-warns-about-unapproved-tadalafil-in.
Source Summary by GovInfoNow · govinfonow.com/recall/36218-hyobin-premierzen-black-50-fda-warns-about-unapproved-tadalafil-in · Updated October 4, 2026 · FDA enforcement record: FDA #D-0382-2021
Cite this page
“Hyobin PremierZen Black 50: FDA Warns About Unapproved Tadalafil in Drug.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36218-hyobin-premierzen-black-50-fda-warns-about-unapproved-tadalafil-in. Based on FDA recall #D-0382-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0382-2021%22&limit=1).
Why it’s dangerous
The FDA detected tadalafil in the product, which is a drug not approved for use in the United States. This means the product was sold without proper regulatory review, potentially causing health risks if taken without medical supervision.
Who’s affected
Anyone who purchased PremierZen Black 5000 capsules from Yolo Studio in Cliffside Park, NJ. People using this product for medical purposes without FDA approval are at highest risk.
How to tell if you have this one
Check for PremierZen Black 5000 capsules in cardboard blisters with one capsule per card. The product was distributed by Yolo Studio in Cliffside Park, NJ and all lots are affected.
- Brand
Hyobin- Category
Drug
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 |
What to do — step by step
Check Product Details
Look for PremierZen Black 5000 capsules in cardboard blisters with one capsule per card.
Questions people ask
Is this product safe to use?
The FDA found tadalafil in this product without approval, so it is not safe for use without medical supervision.
How can I tell if I have the recalled product?
Check for PremierZen Black 5000 capsules in cardboard blisters with one capsule per card, distributed by Yolo Studio in Cliffside Park, NJ.
What should I do if I have this product?
The recall does not specify a remedy, so contact Hyobin LLC for guidance.
Contact Hyobin
We’ve drafted a message you can send Hyobin to request your refund or repair — edit it as you like.
Subject: Recall D-0382-2021 — Hyobin Hyobin Hello, I own a Hyobin that is covered by recall D-0382-2021 from Hyobin. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
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 qwen3:4b on October 4, 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.