FDA MedWatch – Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night by Ummzy:

TOPIC: Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night by Ummzy: Recall – Due to the Presence of Undeclared Tadalafil Sildenafil & Vardenafil

AUDIENCE: Consumer, Health Professional

ISSUE: Ummzy is recalling all lots of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules because FDA analysis has found the product to contain undeclared tadalafil, sildenafil and vardenafil. The presence of tadalafil, sildenafil and vardenafil in Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.

Consumers with underlying medical issues who take Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules with undeclared tadalafil, sildenafil and vardenafil may experience serious health risks. For example, phosphodiesterase (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, Ummzy has not received any reports of adverse events related to this recall.

This tainted product is marketed as a dietary supplement for male sexual enhancement. 

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: Tadalafil, Sildenafil & Vardenafil are ingredients known as phosphodiesterase (PD-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

RECOMMENDATION: 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.

• Consumers that have Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night, which is being recalled should stop using and destroy them.
• Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.