# FDA recall D-0965-2017

> **Organic Herbal Supply** · Class I · drug recall initiated 2017-04-18.

## Product

RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10  count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228782

## Reason for recall

Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin

## Distribution

Nationwide via internet

## Key facts

- **Recall number:** D-0965-2017
- **Recalling firm:** Organic Herbal Supply
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-18
- **Report date:** 2017-07-19
- **Termination date:** 2018-03-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0965-2017

## Citation

> AI Analytics. FDA recall D-0965-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0965-2017. Source: US FDA. Licensed CC0.

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