On March 1, 2025, in the United States, Natural Dior LLC voluntarily recalled Vitafer-L Gold Liquid dietary supplement for undeclared presence of tadalafil. This drug is not acknowledged by dietary supplement because it is a prescription drug for erectile dysfunction. The presence of tadalafil may pose health-damage risks to individuals with pre-existing medical conditions or patients taking nitrates in such products. [1]
This was not stated on the packaging and indicates some intense adverse effects, probably with risky hypotension when used with nitrate medicine. This is intended for consumers’ health preservation against these dangers. It failed the FDA criteria for labeling active drug ingredients in products, hence having to recall this product. [2]
The manufacturer failed to properly classify the active ingredients under the respective regulations and did not validate the purity of the active ingredients before marketing. This is a major compliance violation resulting from the lack of a pharmacological activity test and lack of declaration for the presence of tadalafil in the product. The assessment of raw materials by a third party and Good Manufacturing Practices (GMP) audit were not performed. [3]
The product was found to contain tadalafil, a prescription drug that had not been declared on the product’s ingredient list or allergen panel. Hence making such an act an immediate serious violation concerning the dietary supplement regulations. Thus, the product was immediately recalled from retail and online sites. [5]
Natural Dior LLC issued guidance to consumers:
This recall highlights the necessity for dietary supplement companies to adhere strictly to regulatory requirements.
FRL advises nutraceutical companies to:
This recall emphasizes the emergency of sufficient ingredient verification and regulatory compliance. Nutraceutical brands should comply with FDA guidelines not to become contaminated with unapproved drugs and protect consumer health and trust.
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