CLASS I Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report
PrimeZEN Black, 2000mg, Male Sexual Performance Enhancement recalled
Volt Candy Wholesale Club is recalling PrimeZEN Black, 2000mg, Male Sexual Performance Enhancement blister card, distributed nationwide in the US. The recall was initiated on 13 Feb 2023 and the FDA has classified it as Class I.
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-0453-2023
- FDA event ID
- 91711
- Recalling firm
- Volt Candy Wholesale Club, Diamond Bar, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 Feb 2023
- FDA classified
- 9 Mar 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 13 Feb 2023 | Recall initiated by company | |
| 8 Mar 2023 | Published in enforcement report | +23 days |
| 9 Mar 2023 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Product as listed by the FDA
PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
Where it was distributed
Nationwide in the USA
Stores named: Wholesale Clubs
Questions about this recall
Why was it recalled?
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Which lots are affected?
Lot number: NPINPB 1003, Expiration date: 08/16/2025
Where was it sold?
Nationwide in the USA
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.