Federal Alert: Gold Star Distribution Recalls FDA-Regulated Products Citing Severe Contamination Risks

On December 26, 2025, Gold Star Distribution, Inc. issued a recall of multiple FDA-regulated products in response to serious contamination risks involving rodent and avian contamination. The recall includes a wide range of drugs, medical devices, cosmetics, human foods, and pet foods distributed in three U.S. states. Regulatory inspections found widespread unsanitary conditions at the company’s facility, leading to the risk of bacterial infections such as Salmonella for consumers and pets.

Key points:

  • Gold Star is recalling drugs, medical devices, cosmetics, dietary supplements, human food, and pet food.
  • Products were found contaminated by rodent excreta, urine, bird droppings, and possibly harmful microorganisms.
  • Exposed individuals or animals may face health risks, including Salmonella and leptospirosis.
  • Consumers are advised to destroy affected products without returning them and request refunds.
  • No reported illnesses have been linked to the recalled products as of this announcement.

Below, you’ll find more details on the recall findings, impacted products, and what steps consumers and retailers should take next.

In this article:

What contamination was found?

Gold Star’s recall stems from FDA inspections that discovered unsanitary conditions within the company’s storage facilities. Specific issues included:

  • Rodent excreta and urine in areas storing FDA-regulated products.
  • Bird droppings and evidence of avian contamination.
  • The potential for vermin-related bacterial contamination, such as Salmonella.

These filth-related contaminants pose serious risks to both humans and animals, making the recall imperative to consumer safety.

Which products are affected?

The recall involves all non-frozen and non-refrigerated FDA-regulated items distributed by Gold Star, including:

  • Drugs and over-the-counter medications
  • Medical devices
  • Cosmetics, such as skin and eye care products
  • Human food items
  • Animal (pet) food and dietary supplements

A complete product list is available on the FDA website.

What are the health risks?

Contaminants found in the recalled products may contain harmful microorganisms, including bacteria responsible for serious illnesses. These include:

  • Salmonella: May cause fever, nausea, diarrhea (sometimes bloody), and abdominal pain in healthy individuals. Vulnerable groups, such as infants, elderly individuals, or immunocompromised persons, may face severe complications, including bloodstream infections or arterial conditions.
  • Leptospirosis: This bacterial infection, carried by rodents, can affect both humans and pets, leading to symptoms ranging from mild fever to severe organ damage.

Additionally, contaminated medical devices or cosmetics could lead to infections, skin irritation, or other adverse health reactions. Prompt medical advice is recommended for anyone feeling unwell after exposure.

What should consumers and retailers do?

Consumers and retailers in possession of affected products should take the following steps immediately:

  • Destroy the products: Do not attempt to use or return recalled items to the company.
  • Request refunds: Verify destruction by mailing proof to Gold Star Distribution at 1000 N. Humboldt Ave, Minneapolis, MN 55411. Refunds will be provided upon request.
  • Consult professionals: If you or your pets exhibit symptoms of illness after using these products, seek medical or veterinary advice immediately.
  • Report adverse events: Contact the FDA’s MedWatch program online or via mail or fax to report any health or product safety concerns.

FAQ

  1. Who does this recall affect?
    The recall impacts consumers and retailers in three states (unspecified in this announcement) who purchased the affected FDA-regulated products from Gold Star Distribution.
  2. Are frozen and refrigerated products included?
    No, the recall excludes all frozen and refrigerated items shipped directly to retail stores by the distributor or manufacturer.
  3. How can I find affected products?
    A detailed list of recalled products can be accessed on the FDA website.
  4. What risks do contaminated products pose?
    There is a risk of infection, irritation, or adverse health reactions depending on the type of contamination and the affected product (drugs, devices, food, cosmetics).
  5. How do I report a problem?
    Adverse reactions can be reported to the FDA’s MedWatch Adverse Event Reporting program online, via mail, or fax, or through SmartHub resources.

Conclusion

This recall highlights the importance of strict adherence to sanitary conditions in the storage and handling of products. Consumers and retailers impacted by this recall must act promptly by destroying the affected products and seeking appropriate medical advice if necessary. Reporting any issues to the FDA ensures additional oversight and helps maintain public safety.

Disclaimer

This article is for informational purposes only and does not constitute legal or professional advice. Always consult a qualified professional for regulatory guidance.

FDA announcement and resources

For full information about the FDA announcement, see the link below.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gold-star-distribution-inc-issues-recall-certain-fda-regulated-products-three-states-including-drugs