FDA MedWatch - Hard Dawn by Esupplementsales: Recall - Due to the Presence of Undeclared Tadalafil

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Hard Dawn by Esupplementsales: Recall - Due to the Presence of Undeclared Tadalafil AUDIENCE: Consumer, Health Professional, Pharmacy ISSUE: Esupplementsales is recalling lot number 2107 of Hard Dawn Rise and Shine capsules due to the presence of undeclared Tadalafil. Tadalafil is an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in an FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Hard Dawn Rise and Shine Capsules renders the product an unapproved drug for which safety and efficacy have not been established. Risk Statement: Consumers with underlying medical conditions who take Hard Dawn Rise and Shine with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Esupplementsales has not received any reports of adverse events related to this recall. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: Hard Dawn Rise and Shine capsules are marketed as a dietary supplement for male sexual enhancement. RECOMMENDATIONS: On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay, and other retailers due to hidden and potentially dangerous drug ingredients.  Consumers that have Hard Dawn Rise and Shine Capsules should stop using. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Esupplementsales is notifying its customers and is arranging for return of all recalled products. Consumers with questions regarding this recall can contact the company. Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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