PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: February 28, 2024 Initiated: February 6, 2024 #D-0345-2024

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Today The World
Units Affected
5500 boxes
Distribution
Product distributed nationwide within the United States.
Location
Portland, OR

Frequently Asked Questions

What product was recalled?
Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com. Recalled by Today The World. Units affected: 5500 boxes.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 28, 2024. Severity: Critical. Recall number: D-0345-2024.