What happened
Original notice title
VitalityVita Issues Voluntary Nationwide Recall of VitalityXtra and PeakMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
From the archived source record
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. More Recalls, Market Withdrawals, & Safety Alerts Recalls, Market Withdrawals, & Safety Alerts Recall Resources Enforcement Reports Industry Guidance For Recalls Major Product Recalls FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, 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. VitalityXtra was found to be tainted with sildenafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. PeakMax capsules was found to be tainted with sildenafil and 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 and, therefore, subject to recall. 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 undeclared 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 report
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Published recall notice
- Source checked
- Jul 16, 2026
- Record revision
- 9a4de0181164
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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