# FDA recall D-0032-2018

> **Vitility** · Class I · drug recall initiated 2017-06-22.

## Product

MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; vitility@yahoo.com; www.manofsteelpills.com; UPC 1 0001001378 7.

## Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0032-2018
- **Recalling firm:** Vitility
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-06-22
- **Report date:** 2017-11-01
- **Termination date:** 2018-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sacramento, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0032-2018

## Citation

> AI Analytics. FDA recall D-0032-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0032-2018. Source: US FDA. Licensed CC0.

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