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Recall Observatory FDA recall evidence

Drug product

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

D-0573-2023

April 26, 2023

Class I

Product summary

Firm
Gadget Island, Inc
Event
Event 92203
Status
Ongoing
Classification
Class I
Quantity
140 blister packs
Official record key
drug-enforcement:D-0573-2023

Official wording

Reason: 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.

Code information: Lot/Item#: OMS760-B, Exp: 12/2025

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.