# FDA recall D-0645-2022

> **Positive Health** · Class I · drug recall initiated 2022-02-10.

## Product

RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.

## Reason for recall

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

## Distribution

Product was distributed nationwide via the internet through Amazon Marketplace.

## Key facts

- **Recall number:** D-0645-2022
- **Recalling firm:** Positive Health
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-10
- **Report date:** 2022-03-02
- **Termination date:** 2022-06-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wilmington, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0645-2022

## Citation

> AI Analytics. FDA recall D-0645-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0645-2022. Source: US FDA. Licensed CC0.

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