The Protein Shoppe, LLC announced earlier this week that it is voluntarily recalling every lot of ‘Red-E,’ a male enhancement tablet, to the consumer level. The decision to recall the product came after an “FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active ingredient in an FDA approved drug used in the treatment of erectile dysfunction.” According to the recall notice, “the presence of sildenafil in Red-E renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.”

Red-E Label; image courtesy of the FDA, www.fda.gov

The presence of sildenafil is a serious matter because it may pose serious health risks to anyone with underlying health issues. For example, “PDE-5 inhibitors may interact with nitrates found in some prescription drugs, such as nitroglycerin.” When this happens, a consumer’s blood pressure may decrease to dangerous, life-threatening levels that may result in “serious adverse health consequences.” People with heart disease, high blood pressure, and diabetes are, particularly at risk. However, The Protein Shoppe, LLC has not received a single report of a consumer experiencing adverse reactions from taking Red-E.Prior to the recall, Red-E was marketed as a male enhancement nutritional supplement. It was sold online at www.rgvproteinshoppe.com. For now, the company is notifying customers about the recall and is “arranging for the return of all the recalled products.” Consumers who have the tablets should stop using them and return them for a full refund. If you or someone you know has questions or concerns about the recall, contact The Protein Shoppe at 956-687-3539.

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The Protein Shoppe, LLC Issues Voluntary Nationwide Recall of the “Red- E” Male Enhancement Tablet Due to the Presence of Undeclared SildenafilThe Protein Shoppe, LLC