FDA Drug recall D-0664-2021
Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680
- FDA Drug
- Class I
- terminated
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class I recall of Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680 by Ummzy, citing marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and effic….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0664-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-03-30 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ummzy |
| Distribution | US |
Product
Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
Reason
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Identifiers
| upc | 617135894680 |
|---|---|
| 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: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0664-2021%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.