CLASS I ONGOING Drug recall · Reported 10 May 2023 · FDA Enforcement Report
NUX Male Enhancement capsule blister card recalled by Gadget Island
Gadget Island is recalling NUX Male Enhancement capsule blister card, distributed nationwide in the US. The recall was initiated on 26 Apr 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0572-2023
- FDA event ID
- 92203
- Recalling firm
- Gadget Island, West Sacramento, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 26 Apr 2023
- FDA classified
- 11 May 2023
- Reported
- 10 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
Timeline
| 26 Apr 2023 | Recall initiated by company | |
| 10 May 2023 | Published in enforcement report | +14 days |
| 11 May 2023 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is NUX Male Enhancement capsule blister card recalled?
Yes. Gadget Island recalled NUX Male Enhancement capsule blister card on 26 Apr 2023. The recall is Class I and its status is Ongoing. Recall number D-0572-2023.
Why was it 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.
Which lots are affected?
Lot#: RO 927996, Exp: 12/25/2024
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Gadget Island
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Pro Power Knight Plus capsule, 2550mg blister card recalled | Gadget Island | Labeling Errors | Nationwide |
| Drug | CLASS I | Dynamite Super capsule, 58,000 MG blister card recalled by Gadget Island | Gadget Island | Labeling Errors | Nationwide |
| Drug | CLASS I | Rhino 7 Platinum, Proprietary Material: 750mg packets recalled | Gadget Island | Labeling Errors | Nationwide |
| Drug | CLASS I | PapaZen, Proprietary Blend 1800mg packets recalled by Gadget Island | Gadget Island | Labeling Errors | Nationwide |
| Drug | CLASS I | Fifty Shades, Proprietary Raw Material 4550 packets recalled | Gadget Island | Labeling Errors | Nationwide |