FDA Drug recall D-0572-2023
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3
- FDA Drug
- Class I
- ongoing
- Published 2023-05-10
On 2023-05-10 the FDA classified a Class I recall of NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3 by Gadget Island, citing 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 treatm….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0572-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-04-26 |
| Published | 2023-05-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Gadget Island |
| Distribution | US |
Product
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
Reason
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.
Identifiers
| upc | 601577512363 |
|---|---|
| code_info | Lot#: RO 927996, Exp: 12/25/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0572-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.