VitalityVita Initiates Nationwide Voluntary Recall of VitalityXtra and PeakMax Capsules Over Undeclared Sildenafil and Diclofenac Concerns
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Dietary Supplements
Drugs - Reason for Announcement:
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Recall Reason Description
Undeclared Sildenafil and Diclofenac
- Company Name:
- VitalityVita
- Brand Name:
-
Brand Name(s)
VitalityVita
- Product Description:
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Product Description
Marketed as Dietary Supplement
Company Announcement
FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, VitalityVita.com is conducting a voluntary recall of lot 230811, Exp 8/11/25 for VitalityXtra Capsules and PeakMax Capsules packaged in 10-count blisters. Testing revealed that VitalityXtra contained sildenafil, an ingredient approved by the FDA for the treatment of male erectile dysfunction, while PeakMax was tainted with both sildenafil and diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) utilized for alleviating pain and inflammation. As such, these products cannot be marketed as dietary supplements, and both are classified as unapproved new drugs, prompting the recall.
The presence of undeclared sildenafil poses risks due to potential interactions with nitrates found in some prescription medications, potentially leading to dangerously low blood pressure. Individuals with diabetes, hypertension, high cholesterol, or heart disease, particularly those using nitrates for cardiac issues, are at higher risk during consumption of these products.
Undeclared diclofenac can also raise the risk of major cardiovascular incidents like heart attacks and strokes, in addition to inducing serious gastrointestinal complications, including bleeding, ulceration, and life-threatening ruptures in the digestive tract. Conflicts with other medications can significantly increase the likelihood of adverse effects, especially when multiple NSAID products are used simultaneously. VitalityVita has reported no adverse events associated with this recall as of yet.
The affected products were available for purchase online through VitalityVita.com across the United States.
VitalityVita will inform its distributors and customers through this announcement and is organizing the return of all affected products. Customers should return all recalled items to 2108 N ST #7929 Sacramento, CA 95816. Any consumer in possession of VitalityXtra or PeakMax capsules with the lot number 230811 should discontinue use immediately and consult a physician if any related health issues arise.
For any inquiries regarding this recall, consumers can reach out to VitalityVita via email at vitalityvitacorp@gmail.com during business hours from Monday to Friday, between 9 AM and 5 PM PST.
Reports of adverse reactions or quality issues related to the usage of these products should be submitted to the FDA’s MedWatch Adverse Event Reporting program, which is accessible online, via mail, or by fax.
This recall is being conducted in coordination with the U.S. Food and Drug Administration.