Gadget Island, Inc: Drug Recall

Recall #D-0573-2023 · 04/26/2023

Class I: Dangerous

Recall Details

Recall Number
D-0573-2023
Classification
Class I
Product Type
Drug
Recalling Firm
Gadget Island, Inc
Status
Ongoing
Date Initiated
04/26/2023
Location
West Sacramento, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
140 blister packs

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.

Product Description

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

Distribution Pattern

Nationwide in the USA.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.