Esupplementsales LLC has recalled one lot of Hard Dawn Rise and Shine capsules in the form of capsules, the U.S. Food and Drug Administration or FDA said in a statement. The product is marketed as a dietary supplement for male sexual enhancement.
The company initiated the recall after it was informed by Amazon that laboratory analysis has found the product to be tainted with tadalafil, which 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 by the FDA and for which safety and efficacy have not been established.
The FDA said there have been no reports of adverse events received involving the recalled lot, which was distributed via internet and fulfilled by Amazon at www.amazon.com across the U.S. The recalled product was packaged in 10-count blister cards.
The company warned that consumers with underlying medical issues who take the capsules with undeclared tadalafil may experience serious health risks. The company said the administration of the product containing tadalafil could lower blood pressure to dangerous levels that may be life-threatening.
The ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
The company has urged consumers who have Hard Dawn Rise and Shine capsules, which are under recall, to stop using them and return to place of purchase, which is being arranged by Amazon.
On December 17, 2020, the FDA had 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. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
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