Recalls / Class I
Class ID-0572-2023
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
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
- Affected lot / code info
- Lot#: RO 927996, Exp: 12/25/2024
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
- 18 blister cards
- 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-0572-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.