Hardcore Formulations is recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules. The dietary supplements, promoted for bodybuilding, are labeled to contain methylstenbolone (Ultra-Sten) and dymethazine (D-Zine), which are considered to be derivatives of anabolic steroids. The presence of these ingredients in Ultra Sten and D-Zine render them unapproved drugs for which the safety and efficacy has not been established, according to federal law.
Derivatives of anabolic steroids may cause serious liver injury and other adverse health consequences, including kidney injury, increased risk of heart attack and stroke, decreased high-density lipoprotein (HDL) cholesterol levels, elevated blood pressure, aggressive behavior, male infertility, virilization in women (such as menstrual irregularities, deeper voice, increased body hair, and baldness), and enlarged breasts and shrinkage of the testes in men. People with underlying cardiac, hepatic or prostate conditions may be at higher risk for adverse reactions than otherwise healthy users.
To date, Hardcore Formulations has not received any reports of adverse events related to this recall.
Ultra-Sten and D-Zine capsules are packaged In 90-count bottles with the bar code 7-48252-68763-0 (Ultra-Sten); 7-48252-86193-1 (D-Zine). Affected products were sold through retailers nationwide from August 2014 to May 2017. This recall applies to all lot numbers and expiration dates of Ultra-Sten and D-Zine.
Any adverse events experienced after consuming these dietary supplements should be reported to the Food and Drug Administration MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice