LabidaMAX Herbal Dietary Supplement Capsules recalled over undeclared tadalafil

Recall date

April 18, 2017

Source

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

Official notice title

Organic Herbal Supply recalls LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Made in Malaysia, Distributed by O…

Recall number

D-0971-2017

FDA classification

Class I

Brand / firm

Organic Herbal Supply

Sold / distributed

Nationwide via internet

Why it was recalled

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

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

LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228904