# FDA recall D-0561-2022

> **Esupplementsales, LLC** · Class I · drug recall initiated 2022-01-28.

## Product

HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59

## Reason for recall

Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.

## Distribution

Nationwide in the USA via Amazon at www.amazon.com

## Key facts

- **Recall number:** D-0561-2022
- **Recalling firm:** Esupplementsales, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-28
- **Report date:** 2022-02-16
- **Termination date:** 2022-08-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reno, NV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0561-2022

## Citation

> AI Analytics. FDA recall D-0561-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0561-2022. Source: US FDA. Licensed CC0.

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