VitalityVita Recalls VitalityXtra and PeakMax Capsules Nationwide Due to Undeclared Sildenafil and Diclofenac

On November 4th, 2024, in Sacramento, CA, VitalityVita.com initiated a voluntary recall of lot number 230811, expiring on August 11, 2025, involving its VitalityXtra Capsules and PeakMax Capsules. These products, packaged in 10-count blisters within a cardboard carton, are being recalled from the consumer level. VitalityXtra was discovered to contain sildenafil, an active ingredient used in FDA-approved medications for treating male erectile dysfunction, classified under phosphodiesterase (PDE-5) inhibitors. Additionally, PeakMax Capsules were found to contain both sildenafil and diclofenac, the latter being an FDA-approved nonsteroidal anti-inflammatory drug (NSAID) used for pain and inflammation management. These substances disqualify the products from being marketed as dietary supplements, resulting in the recall since their safety and efficacy remain unverified.

The ingestion of products with undeclared sildenafil poses a risk of severe interactions with nitrates, commonly found in several prescription medications like nitroglycerin, potentially causing life-threatening drops in blood pressure. This risk is particularly significant for individuals with diabetes, hypertension, high cholesterol, or heart disease, who often use nitrates. Male adults, the primary users of these products, are especially at risk if they take nitrates for cardiac conditions.

Similarly, the presence of undeclared diclofenac increases the likelihood of cardiovascular issues such as heart attacks and strokes, along with serious gastrointestinal harm, including bleeding, ulcers, and potentially fatal perforations of the stomach and intestines. Furthermore, diclofenac can interact adversely with other medications, heightening the probability of negative effects, especially when combined with other NSAID-containing products. As of now, no adverse event reports have been received by VitalityVita regarding this recall.

Distributed nationwide through VitalityVita.com, both products are marketed as dietary supplements for enhancing male performance and energy. The VitalityXtra Capsules come in green, yellow, and white cartons, while PeakMax Capsules are in purple, yellow, and white cartons. Both products are identifiable by their respective packaging and lot number 230811, with an expiration date of August 11, 2025.

VitalityVita is actively notifying its distributors and customers about this recall through a press announcement and organizing the return of all affected products. Consumers in possession of VitalityXtra or PeakMax Capsules from the specified lot are advised to discontinue use immediately. They should consult their healthcare providers if they experience any adverse effects potentially related to these products.

For further inquiries related to this recall, consumers can contact VitalityVita via email during business hours from Monday to Friday. Additionally, any adverse reactions or quality issues encountered with these products can be reported to the FDA's MedWatch Adverse Event Reporting program online, by mail, or by fax. This recall is being executed with the full awareness and cooperation of the U.S. Food and Drug Administration.