FDA MedWatch - Red Mammoth by Celebrate Today:

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TOPIC: Red Mammoth by Celebrate Today: Recall - Due to the Presence of Undeclared Sildenafil and Tadalafil

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: Celebrate Today is recalling lot number DK1027 of Red Mammoth capsules because Celebrate Today was informed by Amazon that laboratory analysis has found the product to be tainted with sildenafil and tadalafil, ingredients known as a phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and tadalafil in Red Mammoth capsules renders the product an unapproved drug for which safety and efficacy have not been established.

Risk Statement: Consumers with underlying medical conditions who take Red Mammoth with undeclared sildenafil and 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, Celebrate Today has not received any reports of adverse events related to this recall.

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

BACKGROUND: Red Mammoth capsules are marketed as a dietary supplement for male enhancement.

RECOMMENDATIONS: 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.

• 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.
• Consumers that have Red Mammoth capsules should stop using.
• Celebrate Today is arranging for return of all recalled products.
• Consumers with questions regarding this recall can contact the company.

Consumers and health professionals 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.