CLASS II ONGOING Drug recall · Reported 26 May 2021 · FDA Enforcement Report
PremierZen Extreme recalled by Hyobin
Hyobin is recalling PremierZen Extreme 3000, distributed nationwide in the US. The recall was initiated on 6 Apr 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0381-2021
- FDA event ID
- 87711
- Recalling firm
- Hyobin, Ridgewood, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Apr 2021
- FDA classified
- 14 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Hidden Drug Ingredients
Timeline
| 6 Apr 2021 | Recall initiated by company | |
| 14 May 2021 | Classified by FDA | +38 days |
| 26 May 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
Where it was distributed
USA Nationwide
Questions about this recall
Is PremierZen Extreme 3000 recalled?
Yes. Hyobin recalled PremierZen Extreme 3000 on 6 Apr 2021. The recall is Class II and its status is Ongoing. Recall number D-0381-2021.
Why was it recalled?
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Which lots are affected?
all lots
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hyobin
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Triple SupremeZen Plus recalled by Hyobin | Hyobin | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | PremierZen Black recalled by Hyobin | Hyobin | Hidden Drug Ingredients | Nationwide |