# FDA recall D-0001-2022

> **Alpha-Tek LLC** · Class I · drug recall initiated 2021-07-16.

## Product

ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ  UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)

## Reason for recall

Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0001-2022
- **Recalling firm:** Alpha-Tek LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-07-16
- **Report date:** 2021-10-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tucson, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2022

## Citation

> AI Analytics. FDA recall D-0001-2022. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/D-0001-2022. Source: US FDA. Licensed CC0.

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