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

FDA recall notice · announced April 12, 2017 · Organic Herbal Supply

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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).

Notes

Distribution: Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
Lot/code information: All lots
Quantity: 100,000 to 150,000 capsules
Status: Terminated
Products in this recall event:
- 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 6804742 (D-0646-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.