Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Dietary Supplements
- Reason for Announcement:
-
Recall Reason Description
Undeclared Sildenafil and Tadalafil
- Company Name:
- Celebrate Today
- Brand Name:
- Product Description:
Company Announcement
Brentwood, NY, 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 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. 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).
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.
Celebrate Today 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 Red Mammoth capsules should stop using.
Consumers with questions regarding this recall can contact Brian Dunn at (631) 642-2550, Monday – Friday from 09:00 – 17:00 EST or e-mail [email protected].
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
- Regular Mail or Fax: Download form 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
