CLASS II ONGOING Drug recall · Reported 12 May 2021 · FDA Enforcement Report
PremierZen Extreme 3000, Male Sexual Performance Enhancement recalled
QMart is recalling PremierZen Extreme 3000, Male Sexual Performance Enhancement, distributed nationwide in the US. The recall was initiated on 31 Mar 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-0369-2021
- FDA event ID
- 87751
- Recalling firm
- QMart, Elmwood Park, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Mar 2021
- FDA classified
- 6 May 2021
- Reported
- 12 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Hidden Drug Ingredients
Timeline
| 31 Mar 2021 | Recall initiated by company | |
| 6 May 2021 | Classified by FDA | +36 days |
| 12 May 2021 | Published in enforcement report | +6 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 and/or sildenafil.
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, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Which lots are affected?
All
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 87751This product is part of a recall event; the main page for the event is Imperial Gold 2000, Male Sexual Performance Enhancement recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Imperial Gold 2000, Male Sexual Performance Enhancement recalled | QMart | Hidden Drug Ingredients | Nationwide | |
| CLASS II | Imperial Platinum recalled by QMart | QMart | Hidden Drug Ingredients | Nationwide | |
| CLASS II | Burro en Primavera recalled by QMart | QMart | Hidden Drug Ingredients | Nationwide |
More recalls from QMart
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Burro en Primavera recalled by QMart | QMart | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Imperial Platinum recalled by QMart | QMart | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Imperial Gold 2000, Male Sexual Performance Enhancement recalled | QMart | Hidden Drug Ingredients | Nationwide |