FDAFDA · Food and drugs·Recall number D-0573-2023
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Published May 10, 2023 · Recall initiated: April 26, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gadget Island, Inc
- Distributor
- Nationwide in the USA.
- Lot
- Lot/Item#: OMS760-B, Exp: 12/2025
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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