If You're Taking This Supplement, Stop Immediately, FDA Warns
People who use the sexual enhancement product risk "serious" health consequences.
Plenty of over-the-counter supplements flood the marketplace promising to boost performance in the bedroom. But their claims are often made without proof, and the poorly regulated category is filled with specious promises and even counterfeit products. So would-be users are always wise to approach these sexual enhancement supplements with skepticism and caution, and to do their homework. Now, one such supplement is making headlines as a result of a recall due to serious safety concerns. Here's which product is being recalled and why, plus what you should do if you have it at home right now.
Esupplementsales is recalling some of its Hard Dawn Rise and Shine capsules.
The California-based company Esupplementsales is voluntarily recalling lot number 2107 of Hard Dawn Rise and Shine capsules. The recall happened after Amazon told the company that a laboratory analysis has determined its product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA-approved products for the treatment of male erectile dysfunction. However, because this substance is not approved for use in the Hard Dawn capsules, its presence makes it an unapproved drug for which safety and efficacy have not been established.
The recall was announced on Jan. 28 and published on the U.S. Food & Drug Administration (FDA) website on Jan. 31, 2022.
People who take the unapproved drugs could experience serious health risks.
According to the risk statement associated with the FDA's published recall notice, "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 could interact with nitrates found in some prescription drugs (such as nitroglycerin). This interaction could lower blood pressure to a level that could be dangerous or even life threatening. People who have common conditions such as diabetes, high blood pressure, or heart disease often take nitrates. Fortunately, at this time Esupplementsales has not received any reports of health problems related to these products.
Here's how to tell if you have these supplements at home right now.
Hard Dawn Rise and Shine is marketed as a male sexual enhancement dietary supplement, packaged in blister cards each containing 10 capsules. The affected packages come from lot 2107 and have an expiration date of July 2024. They were distributed online and fulfilled by Amazon around the country.
This recall follows an FDA press release dated Dec. 17, 2020, which warned consumers to avoid certain products found on Amazon, eBay, and other retailers due to hidden drug ingredients that could be dangerous. It also encouraged online marketplaces to work to keep these products off their platforms.
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Here's what to do if you have the recalled supplements at home right now.
EsupplementSales is using the announcement posted on the FDA's site as a way to let customers know about the recall. Plus, it's sending messages to its Amazon customers and arranging for the return of all recalled products. If you have Hard Dawn Rise and Shine capsules at home right now, you should stop using them immediately.
If you have any questions about the recall, you can contact Christopher Green at (916) 626-9275, Monday through Friday from 09:00 AM to 5 pm PST, or email [email protected] If you feel you've experienced any health problems related to taking this supplement, reach out to your doctor directly.
Report any health or quality problems from the use of this product to FDA's MedWatch adverse event reporting program either online, by regular mail using this downloadable form, or by fax to 800-FDA-0178.