Nationwide Recall Issued For Brand Of Supplements Due To 'Serious Health Risks,' FDA Says

A recall has been issued for a supplement after the products were found to be tainted with an undeclared drug that could cause serious health issues.

Esupplementsales, LLC is recalling lot number 2107 of "Hard Dawn Rise and Shine" capsules, which were discovered to be tainted with tadalafil, an ingredient found in an FDA-approved product for the treatment of erectile dysfunction, according to an announcement posted to the Food and Drug Administration's website on Friday, Jan. 28.

"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 and, therefore, subject to recall," the company said.

Those with underlying medical conditions who take the supplement could experience serious health risks, as it could interact with some prescription drugs and lower blood pressure to dangerous levels, according to the announcement.

The product is marketed as "a dietary supplement for male sexual enhancement and is packaged in 10 count blister cards," the announcement reads.

The products included in the recall have an expiration date of 07/2024. They were distributed through Amazon orders across the United States, Esupplementsales, LLC said.

The company said it has not received reports of adverse reactions related to the recall so far.

Consumers that purchased the products should stop using them, the company said. 

Those with questions can call Christopher Green at 916-626-9275 or e-mail HardDawn@yahoo.com. 

Find the full FDA announcement here.

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