PlainRecalls
FDA Drug Critical Class I Ongoing

DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.

Reported: May 10, 2023 Initiated: April 26, 2023 #D-0573-2023

Product Description

DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.

Reason for Recall

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Details

Recalling Firm
Gadget Island, Inc
Units Affected
140 blister packs
Distribution
Nationwide in the USA.
Location
West Sacramento, CA

Frequently Asked Questions

What product was recalled?
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.. Recalled by Gadget Island, Inc. Units affected: 140 blister packs.
Why was this product recalled?
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 10, 2023. Severity: Critical. Recall number: D-0573-2023.