Safety Report: Hard Dawn Rise and Shine capsules - recalled due to Undeclared Tadalafil, USA

United States

Esupplementsales, LLC is voluntarily recalling lot number 2107 of Hard Dawn Rise and Shine capsules to the consumer level. Esupplementsales, LLC was informed by Amazon that laboratory analysis has found the product to be tainted with tadalafil, which renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Tadalafil is an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in an FDA approved product for the treatment of male erectile dysfunction.

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.

Hard Dawn Rise and Shine capsules are marketed as a dietary supplement for male sexual enhancement and is packaged in 10 count blister cards. The affected Hard Dawn Rise and Shine packages include lot 2107 an expiration date of 07/2024. The product can be identified by the label below and was distributed via internet and fulfilled by Amazon at www.amazon.com nationwide.

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. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

EsupplementSales, LLC is notifying its customers by this press announcement and sending Amazon messages to its customers and is arranging for return of all recalled products. 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Esupplementsales, LLC
Brand name: Hard Dawn
Product recalled: Hard Dawn Rise and Shine capsules
Reason of the recall: Undeclared Tadalafil
FDA Recall date: January 31, 2022

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/esupplementsales-llc-issues-nationwide-recall-all-lots-hard-dawn-due-presence-undeclared-tadalafil

Source: FDA