COMPANY ANNOUNCEMENT
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.
Read Announcement View Product PhotosSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Dietary Supplements
Drugs - Reason for Announcement:
-
Recall Reason Description
Undeclared Tadalafil
- Company Name:
- Natural Dior LLC
- Brand Name:
-
Brand Name(s)
- Product Description:
-
Product Description
Company Announcement
FOR IMMEDIATE RELEASE - Natural Dior LLC (USA) – February 25, 2025 – Natural Dior LLC, is voluntarily recalling the affected lots of Vitafer-L Gold Liquid, a dietary supplement with iron and vitamins, to the consumer level. The product has been found to contain undeclared tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Products containing tadalafil cannot be marketed as dietary supplements. Vitafer-L Gold Liquid is an unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Consumption of products with undeclared tadalafil 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. To date, Natural Dior LLC has not received any reports of adverse events related to this recall.
The product is used as a state indication(s) and is packaged in 16.9 fl oz (1.06 pt) 500 mL bottles in a folding cardboard box.
-
Lot Numbers and Expiration Dates:
- Lot 7021-2304 – Exp. April 2025
- Lot 7017-2304 – Exp. April 2025
- Lot 7040-2305 – Exp. May 2025
- Lot 10020-2402 – Exp. February 2026
- Lot 10011-2404 – Exp. April 2026
- Lot 7695-2307 – Exp. Not specified
- Lot R6715-2303 – Exp. March 2025
- Lot 7292-2305 – Exp. May 2025
- Lot 9669-2403 – Exp. March 2025
- Lot 10060-2404 – Exp. April 2026
The product was sold nationwide via Amazon and Walmart and distributed through wholesale accounts. The product was also exported to Miami, Florida, through an importer (Laboratorio Natural Dior LLC).
Consumers who have purchased this product should stop using it immediately and dispose of it properly or return it to the place of purchase for a refund.
Consumers with questions regarding this recall can contact Natural Dior LLC at +57 315 2814091 from 10AM - 5PM or via email at vitafer.original@gmail.com.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax. No adverse reactions have been reported to Natural Dior LLC (USA) as of February 20, 2025
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Natural Dior LLC is committed to ensuring the safety and quality of its products and is taking all necessary steps to remove the affected product from the market.
