ALPHA MALE+ Male Enhancer — Class I drug recall D-0001-2022
Ongoing recall by Alpha-Tek LLC, reported 2021-10-13, distributed nationwide. Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
| Recall number | D-0001-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alpha-Tek LLC, Tucson, AZ, United States |
| Recall initiated | 2021-07-16 |
| Classified | 2021-10-04 |
| Reported by FDA | 2021-10-13 |
| Distributed | Nationwide (US) |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00860003037706, 00860003745120, 00860003745182 |
Product
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
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-0001-2022. 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.