FDA Drug recall D-0001-2022
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. A…
- FDA Drug
- Class I
- ongoing
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class I recall of 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. A… by Alpha Tek, citing marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0001-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-07-16 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alpha Tek |
| Distribution | US |
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
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Identifiers
| upc | 860003037706 |
|---|---|
| upc | 860003745182 |
| upc | 860003745120 |
| code_info | All lots within expiry |
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-0001-2022%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.