# FDA recall D-037-2013

> **XRock Industries, LLC** · Class I · drug recall initiated 2012-04-21.

## Product

X-ROCK  For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312,   0 00309 50792 7.                             UPC on labeling is:  0 00309 50792 7.    UPC in Press Release is:  0030950792.

## Reason for recall

Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil.  Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).

## Distribution

Products were distributed nationwide and internationally to Australia, Bahamas, Bermuda, Canada, Croatia, Curacao, New Zealand, Trinidad and Tobago, U.S. Virgin Islands, Jamaica, and United Kingdom.

## Key facts

- **Recall number:** D-037-2013
- **Recalling firm:** XRock Industries, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-04-21
- **Report date:** 2012-11-07
- **Termination date:** 2015-11-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pompano Beach, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-037-2013

## Citation

> AI Analytics. FDA recall D-037-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-037-2013. Source: US FDA. Licensed CC0.

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