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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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.
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