Thumbs up 7 Red 70K capsules — Class I drug recall D-0664-2021
Terminated recall by Ummzy, LLC, reported 2021-07-28, distributed nationwide. Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and v
| Recall number | D-0664-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ummzy, LLC, Palisades Park, NJ, United States |
| Recall initiated | 2021-03-30 |
| Classified | 2021-07-16 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2022-06-09 |
| Distributed | Nationwide (US) |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00617135894680 |
Product
Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
Reason for recall
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.
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-0664-2021. 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.