Arize Herbal Dietary Supplement recalled over undeclared nortadalafil

Recall date

February 6, 2024

Source

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

Official notice title

Today The World recalls Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenn…

Recall number

D-0345-2024

FDA classification

Class I

Brand / firm

Today The World

Sold / distributed

Product distributed nationwide within the United States.

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

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

Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com