Organic Herbal Supply recalls XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in…

Recall date

February 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0646-2017

FDA classification

Class I

Brand / firm

Organic Herbal Supply

Sold / distributed

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

Why it was recalled

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).

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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