Safety Report: VitalityXtra and PeakMax Capsules - recalled due to Sildenafil and Diclofenac, USA

United States

VitalityVita.com is voluntarily recalling lot 230811, Exp 8/11/25, of VitalityXtra Capsules and PeakMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level due to Sildenafil and Diclofenac. The products were distributed via the internet at VitalityVita.com nationwide in the USA.

Sildenafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Diclofenac, an FDA approved drug known as a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation.

Products containing sildenafil and diclofenac cannot be marketed as dietary supplements. VitalityVita and PeakMax capsules are unapproved new drugs for which safety and efficacy have not been established.

Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.

Use of products with diclofenac may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. To date, VitalityVita has not received any reports of adverse events related to this recall.

VitalityXtra and PeakMax are marketed as dietary supplements for male performance and energy and are packaged in 10-count blisters packaged in an (VitalityXtra -Green, Yellow White Carton) and (PeakMax in Purple, Yellow and White carton) Lot#: 230811 Exp 8/11/25. The product can be identified by the labels below.

Distributors and customers can return of all recalled products for the refund.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: VitalityVita
Brand name: VitalityVita
Product recalled: VitalityXtra and PeakMax Capsules
Reason of the recall: Undeclared Sildenafil and Diclofenac
FDA Recall date: November 06, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vitalityvita-issues-voluntary-nationwide-recall-vitalityxtra-and-peakmax-capsules-due-presence