The Recall Desk
SevereFDA (Drugs)·D-0573-2023·Announced 2023-05-10

Unapproved Drug Capsule Recalled for Undeclared Sexual Enhancement Ingredients

DYNAMITE SUPER capsule is being recalled nationwide because it was marketed without FDA approval and contains undeclared sildenafil and tadalafil, active ingredients used in sexual enhancement products.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires minimum severity level 4. The product is an unapproved drug marketed with undeclared active pharmaceutical ingredients (sildenafil and tadalafil), presenting serious health risks. No deaths or serious injuries are reported in the source text.

Plain-English summary

DYNAMITE SUPER capsule (58,000 MG, 1-count blister card) manufactured by Gadget Island, Inc. is being recalled. The product (lot OMS760-B, expiration date 12/2025) was distributed nationwide in the United States.

FDA analysis found that the product contains undeclared sildenafil and tadalafil, active pharmaceutical ingredients used in FDA-approved medications for the treatment of male sexual enhancement. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), making it an unapproved drug.

This recall applies to all consumers nationwide who may have purchased this product with lot number OMS760-B.

The recalled product

Product
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Manufacturer
Gadget Island, Inc
Category
Drug
Hazard
Affected units
140

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot/Item#: OMS760-B
  • Exp: 12/2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Gadget Island, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Gadget Island, Inc

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Same hazard · undeclared ingredients

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