Safety Report: Red Mammoth Capsules - recalled due to undeclared Sildenafil and Tadalafil, USA

United States

Celebrate Today is voluntarily recalling lot number DK1027, Exp 08/01/2023 of Red Mammoth capsules to the consumer level. Celebrate Today was informed by Amazon that laboratory analysis has found the product to be tainted with sildenafil and tadalafil, ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The product can be identified by the label below and was distributed and fulfilled by Amazon at www.amazon.com nationwide in the USA (for a period of 13 months.

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 and, therefore, subject to recall.

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.

Red Mammoth capsules are marketed as a dietary supplement for male enhancement and is packaged in 10 ct. blister cards packaged in a carton. The affected Red Mammoth packages include lot DK1027 with an expiration date of 08/01/2023.

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 that have Red Mammoth capsules should stop using.

Company name: Celebrate Today
Brand name: Red Mammoth
Product recalled: Red Mammoth Capsules
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: February 08, 2022

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/celebrate-today-issues-nationwide-recall-one-lot-red-mammoth-due-presence-undeclared-ingredients

Source: FDA