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In the recall notice of February 25, 2025, Natural Dior LLC voluntarily issued the recall of Vitafer-L Gold due to the presence of undeclared tadalafil in certain lots of Vitafer-L Gold Liquid. The liquid contains iron and vitamin dietary supplements. This information is available at FDA on February 26, 2025. Tadalafil is the active ingredient in FDA-approved prescription medicines and is used in treating erectile dysfunction. It is illegal for tadalafil to be marketed as part of a dietary supplement. The FDA considers this to be an unapproved new drug whose safety and effectiveness have not been proven. [1]

FDA Recall Alert: Natural Dior Vitafer-L Gold Liquid (Undeclared Tadalafil)

Recall ,July 30, 2026

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Category of the Product: Dietary Supplements

Type of the Product: Iron and Vitamin Dietary Supplement

Reason for Announcement: Vitafer-L Gold recall due to the undeclared presence of tadalafil, a prescription drug ingredient, in the dietary supplement.

In the recall notice of February 25, 2025, Natural Dior LLC voluntarily issued the recall of Vitafer-L Gold due to the presence of undeclared tadalafil in certain lots of Vitafer-L Gold Liquid. The liquid contains iron and vitamin dietary supplements. This information is available at FDA on February 26, 2025. Tadalafil is the active ingredient in FDA-approved prescription medicines and is used in treating erectile dysfunction. It is illegal for tadalafil to be marketed as part of a dietary supplement. The FDA considers this to be an unapproved new drug whose safety and effectiveness have not been proven. [1]

Why Was Vitafer-L Gold Liquid Recalled?

Reason for Warning

Vitafer-L Gold recall notice was due to the discovery of undeclared tadalafil, the active ingredient in prescription FDA-approved medicines that are used to treat erectile dysfunction. As tadalafil is not declared in the product label, there may be health hazards risks, particularly for individuals taking nitrate medications.

 

Root Cause: Manufacturing & Testing

Root Cause Analysis

As per the FDA recall notice, the company Natural Dior LLC voluntarily recalled the product as it was found to have undeclared tadalafil content in it. As per the FDA recall notice, products with tadalafil cannot be labeled as dietary supplements, and Vitafer-L Gold Liquid is an unapproved drug with its safety and effectiveness unknown. FDA recall notice does not give any clue regarding the origin of the undeclared substance, nor it gives any information regarding any failure in manufacturing, suppliers, testing, and packaging processes. [2]

Product Description

Product

Details

Brand

Natural Dior LLC

Product

Vitafer-L Gold Liquid

Product Type

Dietary supplement with iron and vitamins

Package Size

16.9 fl oz (1.06 pt) / 500 mL bottle in a folding cardboard box

Issue

Undeclared tadalafil

 

Vitafer-L Gold lot numbers

  • 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 – Expiration 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 affected product was sold nationwide through Amazon, Walmart, wholesale accounts, and was exported to Miami, Florida, through an importer (Laboratorio Natural Dior LLC). [1]

Health Risks and Danger

Health Issue Identified

As per the FDA, the side effects of Vitafer-L Gold Liquid may result from the presence of an undeclared ingredient, tadalafil, which may interact with the nitrates present in some prescribed medicines. The interaction between tadalafil and nitrates may lead to severe reduction in blood pressure, that can be life-threatening.

The individuals who suffer from diabetes, high blood pressure, high cholesterol levels, or heart problems and consume nitrate medicines are more prone to adverse events. Among the adult males, the ones taking nitrate medicines for their hearts are regarded as most vulnerable.

As per the recall notice, Natural Dior LLC has not reported any adverse events due to this recall till date. [3]

FDA Recall Case Study: Vitafer-L Gold Liquid Adulteration

Concerns from Regulatory Body

FDA Regulations on Prescription Drugs in Supplements

Key Regulatory Considerations

  • Supplements having undeclared tadalafil cannot be marketed as dietary supplements.
  • Vitafer-L Gold Liquid has been considered as an unapproved new drug by the FDA, since its safety and effectiveness have not been established.
  • The FDA supplement recall 2025 has been done to safeguard consumers from the hazards of undisclosed drug substances.

Manufacturer and Consumer Guidance

For Consumers

The FDA and Natural Dior LLC recommend that consumers:

  • Stop the use of Vitafer-L Gold Liquid
  • Dispose of the product properly or take it back to the point of purchase for a refund.
  • Conduct a consultation with a doctor/healthcare professional if there is a possibility that their health issue is associated with the use of the product.
  • Report the adverse events to FDA MedWatch Adverse Event Reporting Program.

For Manufacturer

According to the FDA, Natural Dior LLC voluntarily initiated the consumer-level recall of the affected lots after identifying the presence of undeclared tadalafil in the product. [4]

FRL Industry Insights: How to Prevent Supplement Recalls

FRL Commentary

The Vitafer-L Gold recall case emphasizes the significance of effective quality management and regulatory compliance in the dietary supplement production.

Food Research Lab recommends:

  • Ingredient identification verification
  • Raw material qualification
  • Supplier verification
  • Product formulation review
  • Label compliance verification
  • Good Manufacturing Practices (GMP)
  • Quality assurance testing
  • Regulatory compliance documentation

Implementing these measures can help manufacturers reduce regulatory risks, improve product quality, and strengthen consumer confidence.

Conclusion

The Recall of Natural Dior LLC shows the significance of declaring the ingredients truthfully and adhering to FDA guidelines for dietary supplements. FDA Supplement Recall 2025 stresses the significance of an efficient quality control system to avoid undeclared tadalafil in dietary supplements and protect consumer health.

Food Research Lab assists dietary supplement manufacturers in terms of product development, analytical testing, regulatory compliance, quality assurance, and commercialization services to promote the availability of safe and compliant products on the market.

Frequently Asked Question

According to FDA, the undeclared tadalafil may have an interaction effect with nitrates which are present in many prescription drugs, particularly nitroglycerin, resulting in a severe reduction of the blood pressure level that may be life-threatening.

According to FDA, the undeclared tadalafil may have an interaction effect with nitrates which are present in many prescription drugs, particularly nitroglycerin, resulting in a severe reduction of the blood pressure level that may be life-threatening.

The recall includes multiple Vitafer-L Gold lot numbers, including 7021-2304, 7017-2304, 7040-2305, 10020-2402, 10011-2404, 7695-2307, R6715-2303, 7292-2305, 9669-2403, and 10060-2404.

Consumers need to immediately discontinue using the drug, properly dispose of it, return the item back to the retailer or receive the refund, and report any health issues caused by the use of the product.

Manufacturers can decrease the possibility of having the same problem in their products by adopting proper ingredient verification, supplier qualification, quality assurance testing, labeling check, and Good Manufacturing Practices (GMP). These are industry best practices that support product safety and regulatory compliance.

References

  1. S. Food and Drug Administration. (2025). Natural Dior LLC issues voluntary nationwide recall of Vitafer-L Gold Liquid due to presence of undeclared tadalafil. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-dior-llc-issues-voluntary-nationwide-recall-vitafer-l-gold-liquid-due-presence-undeclared
  2. com. (2025). Natural Dior LLC issues voluntary nationwide recall of Vitafer-L Gold Liquid due to presence of undeclared tadalafil. https://www.drugs.com/fda/natural-dior-llc-issues-voluntary-nationwide-recall-vitafer-l-gold-liquid-due-presence-undeclared-14733.html
  3. Drug Office, Department of Health, The Government of the Hong Kong Special Administrative Region. (2025). The United States: Natural Dior LLC issues voluntary nationwide recall of Vitafer-L Gold Liquid due to presence of undeclared tadalafil. https://www.drugoffice.gov.hk/eps/news/showNews/The+United+States%3A+Natural+Dior+LLC+issues+voluntary+nationwide+recall+of+Vitafer-L+Gold+Liquid+due+to+presence+of+undeclared+tadalafil/consumer/2025-02-28/en/55034.html
  4. Food Poisoning Bulletin. (2025). Vitafer-L Gold Liquid supplement recalled as unapproved drug. https://foodpoisoningbulletin.com/2025/vitafer-l-gold-liquid-supplement-recalled-as-unapproved-drug/
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