# FDA recall D-0667-2016

> **Nuway Distributors, LLC** · Class I · drug recall initiated 2015-12-23.

## Product

APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL  USA; UPC 7 05105 96361 7.

## Reason for recall

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.

## Distribution

All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed nationwide.

## Key facts

- **Recall number:** D-0667-2016
- **Recalling firm:** Nuway Distributors, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2015-12-23
- **Report date:** 2016-02-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orlando, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0667-2016

## Citation

> AI Analytics. FDA recall D-0667-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0667-2016. Source: US FDA. Licensed CC0.

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