Miracle 8989 is recalling PremierZEN Gold 7000, PremierZEN Platinum 8000, and maXXzen Platinum 12000 dietary supplement capsules because they were found to contain sildenafil and tadalafil. These are active drug ingredients found in FDA-approved prescription drugs for erectile dysfunction but are not listed on the labels and were marketed without approval. All lots of these products remaining within their expiration dates are included in this recall, which were distributed nationwide in the United States.
The undeclared sildenafil and tadalafil can interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous or even life-threatening levels. This is a particular risk for consumers with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates.
Drug recall refund/guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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