# FDA recall D-0664-2021

> **Ummzy, LLC** · Class I · drug recall initiated 2021-03-30.

## 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.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0664-2021
- **Recalling firm:** Ummzy, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-30
- **Report date:** 2021-07-28
- **Termination date:** 2022-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Palisades Park, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0664-2021

## Citation

> AI Analytics. FDA recall D-0664-2021. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0664-2021. Source: US FDA. Licensed CC0.

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