Recalls / Class I
Class ID-0573-2023
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
- Affected lot / code info
- Lot/Item#: OMS760-B, Exp: 12/2025
Why it was recalled
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.
Recalling firm
- Firm
- Gadget Island, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1275 Halyard Dr Ste 175, West Sacramento, California 95691
Distribution
- Quantity
- 140 blister packs
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-04-26
- FDA classified
- 2023-05-11
- Posted by FDA
- 2023-05-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0573-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.