# FDA recall D-325-2013

> **Consumer Concepts, Inc.** · Class I · drug recall initiated 2013-04-01.

## Product

ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts.

## Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-325-2013
- **Recalling firm:** Consumer Concepts, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-04-01
- **Report date:** 2013-05-22
- **Termination date:** 2018-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Roscoe, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-325-2013

## Citation

> AI Analytics. FDA recall D-325-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-325-2013. Source: US FDA. Licensed CC0.

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