Male sexual enhancement drug recalled after Amazon said it has the generic of Cialis
One lot of Hard Dawn Rise and Shine, marketed as a dietary supplement for male sexual enhancement and found at Amazon.com, was recalled by EsupplementSales.
Here’s what you need to know:
What’s recalled and why?
Lot No. 2107 with expiration 07/2024 of Hard Dawn Rise and Shine, in 10-capsule blister cards, is being pulled. It was sold online and distributed by Amazon.
The EsupplementSales-written, FDA-posted recall notice says the company “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.”
Tadalafil is the generic name of the prescription male sexual enhancement drug Cialis.
So, what’s the problem?
With tadalafil, Hard Dawn Rise and Shine hasn’t been tested by the FDA for safety and efficacy (whether or not it works), thus is an unapproved drug.
Neither the FDA nor the company is saying the capsules don’t work. But no FDA testing confirms they do work at any level, although they do have tadalafil.
As for specific safety problems, the recall notice’s Risk Statement says, “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.”
What do you do now?
Officially, the company says stop using the capsules and that it’s arranging for the supplement’s return.
If you have questions about the recall, email HardDawn@yahoo.com or call Christopher Green at 916-626-9275, Monday through Friday, noon to 8 p.m., Eastern time.
If this or any other drug or drug dispenser causes a medical problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088. Then, notify the manufacturer.
