# FDA recall D-0646-2017

> **Organic Herbal Supply** · Class I · drug recall initiated 2017-02-16.

## Product

XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768

## Reason for recall

Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).

## Distribution

Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com

## Key facts

- **Recall number:** D-0646-2017
- **Recalling firm:** Organic Herbal Supply
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-16
- **Report date:** 2017-04-12
- **Termination date:** 2017-09-13

- **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-0646-2017

## Citation

> AI Analytics. FDA recall D-0646-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0646-2017. Source: US FDA. Licensed CC0.

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