NUX Male Enhancement capsule — Class I drug recall D-0572-2023
Ongoing recall by Gadget Island, Inc, reported 2023-05-10, distributed nationwide. Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and
| Recall number | D-0572-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gadget Island, Inc, West Sacramento, CA, United States |
| Recall initiated | 2023-04-26 |
| Classified | 2023-05-11 |
| Reported by FDA | 2023-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 18 blister |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00601577512363 |
| Lot numbers | 927996 |
| Expiration dates | 2024-12-25 |
Product
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0572-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.