On February 6, 2025, the FDA issued a nationwide recall of Vitality Capsules by One Source Nutrition, Inc. following laboratory tests that detected the presence of two undeclared drugs: sildenafil and tadalafil. These are active ingredients found in prescription medications for erectile dysfunction. When consumed without falter, these substances become more dangerous to comparatively healthy individuals, as well as individuals with other conditions who are taking medications such as nitrates. [1]

Vitality Capsules – One Source Nutrition, Inc. (USA)

Recall , May 14, 2025

On February 6, 2025, the FDA issued a nationwide recall of Vitality Capsules by One Source Nutrition, Inc. following laboratory tests that detected the presence of two undeclared drugs: sildenafil and tadalafil. These are active ingredients found in prescription medications for erectile dysfunction. When consumed without falter, these substances become more dangerous to comparatively healthy individuals, as well as individuals with other conditions who are taking medications such as nitrates. [1]

Reason Behind the Recall

The capsules were revealed to contain undeclared active ingredients: sildenafil and tadalafil—not mentioned on the label but known to cause potentially dangerous side effects like extreme hypotension, harm to the heart, and other complications, particularly in individuals taking nitrate medications or with previous cardiovascular problems. To remove the risk to unwary consumers, the product was taken off the market. [2]

Root Cause Analysis

The manufacturer has not established a proper ingredient verification and third-party testing that could have identified undeclared pharmaceutical ingredients. Even there is no Good Manufacturing Practice (GMP) audit or independent verification of raw materials to ensure that the product can conform to health and safety standards.

Product Description

Brand: One Source Nutrition
Product: Vitality Capsules
Use: Male enhancement, sexual performance, and stamina boost
Issue: Undeclared sildenafil and tadalafil
Recall Classification: Class II (Product is adulterated and potentially hazardous) [3]

Issue Identified

An issue has emerged whereby tests have confirmed the presence of the active ingredients’ sildenafil and tadalafil that are used in prescription drugs to treat erectile dysfunction, but which were not declared on the product label. This represents serious health risks to individuals suffering from cardiovascular disorders or those using other medications such as nitrates. According to FDA guidelines, this has been considered an adulterated product under the FD&C Act. [4]

Regulatory Body Concerns

The presence of undeclared drugs of sildenafil and tadalafil has been considered as a serious violation of the Federal Food, Drug, and Cosmetic Act by the FDA.
Improper disclosure of pharmaceutical ingredients in the product prompted regulatory action under applicable FDA dietary supplement provisions.
The FDA has withdrawn the product from retail and online stores and official recall notices have alerted the public. [1]

Manufacturer’s Consumer Guidance

One Source Nutrition recommends the following:

The consumer should stop using the product immediately.
Refunds or exchanges for affected products should be processed by the company.
In the event of adverse health effects, consumers should inform their health care provider or report to FDA MedWatch.
The company has committed to reviewing its testing and labeling procedures and will improve its ingredient verification in the future. [4]

FRL Commentary

The present recall brings into consideration the necessity for rigorous ingredient testing and accurate labeling regarding dietary supplements.

Accordingly, FRL would suggest nutraceutical companies to:

For each batch, perform complete toxicological evaluation and third-party ingredient testing.
Production should be ideally in accordance with Good Manufacturing Practices (GMP) with raw material verification through independent laboratories.
For maximum transparency, label products clearly and accurately with any ingredients that could be considered pharmaceutical in nature.

Concluding Remarks

This recall reinforces the fact that transparency of ingredients and regulatory compliance are serious considerations in the consumer safety chain. Dietary supplements with claims relating to sexual performance or enhancement should be given due diligence to avoid serious health risks. The integrity of labeling and testing procedures remains the key to consumer trust and safety concerning the nutraceutical market.

For further information, refer to the official FDA Recall Notice for the product.