FDA Issues Recall for Dietary and Sexual Supplements Due to Adverse Reactions

Recently, the U.S. Food & Drug Administration called for HardMenStore.com, an erotic retailer geared towards men, to recall 430 lots of its Silver Sword and Clalis brand dietary and sexual supplements. According to the recall notice, the supplements contain amounts of the PDE-5 Inhibitor Sildenafil that can cause reactions usually associated with the active ingredient in the enhancement pill Viagra.

The pills could be harmful for consumers because they can potentially lead to lower blood pressure, light-headedness and dizziness. The tan and red Silver Sword tin contains eight doses with two pills per dose, while Clalis is packaged in a blue box with a bottle of six pills. The affected lots were produced on or before April 2, 2013, and the date of production can be found on the back of the packaging of both products.

An article by Medscape warns consumers about the potential misleading information coming from manufacturers and marketers of sexual enhancement or supplementary drugs. According to the article, “many consumers are placing their trust in products promoted by manufacturers who do not invest the funds to carry out research to prove the safety and efficacy of these products.” HardMenStore.com states its products were sealed, packaged and delivered to the online retailer as “having contained only legitimate and lawful ingredients.”

The company is currently notifying distributors and consumers with an email and an online press release. The company will arrange for the return of all the affected lots. For now, it is recommended that all consumers and retailers who possess the product should immediately stop using it, and should contact a physician if there have been any side effects from the use of the product.

HardMenStore.com can be contacted through email at info@hardmenstore.com.