# FDA recall D-0453-2023

> **Volt Candy Wholesale Club** · Class I · drug recall initiated 2023-02-13.

## Product

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.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0453-2023
- **Recalling firm:** Volt Candy Wholesale Club
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-13
- **Report date:** 2023-03-08
- **Termination date:** 2024-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Diamond Bar, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0453-2023

## Citation

> AI Analytics. FDA recall D-0453-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0453-2023. Source: US FDA. Licensed CC0.

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