# FDA recall D-0563-2022

> **ABC Sales 1 Inc** · Class I · drug recall initiated 2022-02-08.

## Product

MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.

## Reason for recall

Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.

## Distribution

Product was distributed nationwide in the USA via Amazon Marketplace.

## Key facts

- **Recall number:** D-0563-2022
- **Recalling firm:** ABC Sales 1 Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-08
- **Report date:** 2022-02-23
- **Termination date:** 2022-03-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Monsey, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0563-2022

## Citation

> AI Analytics. FDA recall D-0563-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0563-2022. Source: US FDA. Licensed CC0.

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