Dietary Supplement Sold on Amazon Recalled for Containing Prescription Drug Ingredients

This is a reprint of an FDA Alert.

Esupplementsales, LLC Issues a Nationwide Recall All Lots of Hard Dawn Due to the Presence of Undeclared Tadalafil

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.

Company Announcement Date:
January 28, 2022
FDA Publish Date:
January 31, 2022

Company Contact Information
Consumers:
Christopher Green
916- 626-9275

Company Announcement
FOR IMMEDIATE RELEASE – 01/28/2022 – Orangevale, CA, 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, 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 and, therefore, subject to recall.

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, LLC has not received any reports of adverse events related to this recall.

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 with questions regarding this recall can contact Christopher Green at (916) 626-9275, Monday – Friday from 09:00 – 17:00 PST or e-mail HardDawn AT yahoo DOT com. 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.