Cold and flu medicine urgently recalled after rodent feces discovery

A batch of popular over-the-counter cold and flu medicines is being urgently recalled over the discovery of possible animal contamination, which could result in the presence of salmonella. 

Gold Star Distribution, Inc. has issued an urgent recall of all U.S. Food and Drug Administration (FDA)-regulated products held at its Minneapolis facility after the FDA found evidence of rodent feces, bird droppings, and other forms of contamination. 

The December 26 recall includes cold and flu medications, dietary supplements, food, pet food, cosmetics, and medical devices distributed mainly in Minnesota. 

No illnesseslinked to the recall have been reported so far.

Why It Matters

This comprehensive recall affects a broad range of consumer health products at a time when cold and flu cases are surging in the United States. 

According to the company’s announcement, “Persons handling or consuming the products could become seriously ill due to adulteration from pests, including rodents, birds, and insects.”

What To Know

The FDA’s investigation determined that Gold Star Distribution’s facility operated under conditions that failed health and safety standards, with identified risks tied to contaminated surfaces and airborne particulates from animal waste. 

It found evidence of alarming sanitation failures, including the presence of rodent excreta, urine, and avian contamination in storage areas. 

This creates a heightened risk of exposure to harmful microorganisms, posing threats such as salmonella and leptospira infections to a wide spectrum of consumers, especially the most vulnerable groups such as infants, the elderly, pregnant individuals, immunocompromised patients, and pets.

There has been an immediate recall of all FDA-regulated products housed at the facility, which include:

• Drugs and over-the-counter medications (including cold and flu products)
• Medical devices
• Cosmetics
• Dietary supplements
• Human and animal (pet) food products

The recall notice highlights that “products held under insanitary conditions may become contaminated through contact with contaminated surfaces or exposure to airborne particulates associated with animal waste.”

The potential for bacterial contamination, especially with salmonella, is emphasized due to serious illness risks that include fever, diarrhea, nausea, vomiting, and severe complications for high-risk populations.

The recall applies only to items held at the Gold Star facility. It does not affect products shipped directly to retail or convenience stores from manufacturers or distributors, such as frozen and refrigerated items. 

Recalled Cold And Flu Products

Cold and flu products impacted by the recall include: 

• Liquid DayQuil 12/8oz
• DayQuil Cold & Flu 32CT/2PK
• Children’s NyQuil Cold & Flu Berry 8oz 12ct
• Liquid NyQuil Cherry 12/8oz
• NyQuil Cold & Flu 32CT/2PK
• Tylenol 500 MG. 2’S 50CT
• Tylenol Cold & Flu 25CT/2S
• Tylenol Cold & Flu Severe 2PK *50CT
• Tylenol PM 50CT
• Tylenol Sinus Severe 2PK *50CT
• Excedrin 2’S DISP.- 30
• Motrin IB 50CT
• Alka Seltzer Plus Cold 2/36 box
• Alka-Seltzer Original 2/58CT BX
• Benadryl 25’S 2PK BOX
• Advil Ibuprofen Tablets 50CT
• Advil PM 2PK / 50CT

For a full list of affected products, consumers are encouraged to visit the FDA website.

What People Are Saying

Gold Star said: “Products held under insanitary conditions may become contaminated… Exposure to contaminated products can pose serious health risks to consumers, including the potential for bacterial contamination, which may result in illness or infection, including salmonella.”

It added: “Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program.”

What Happens Next

Gold Star Distribution advises that affected products should not be returned to the company. Instead, consumers and retailers must destroy the products and provide a receipt of destruction to Gold Star to qualify for a refund.

For verification and a refund, proof of product destruction should be sent to Gold Star Distribution at 1000 N. Humboldt Ave, Minneapolis, MN 55411. 

Consumers can contact Gold Star at 612-617-9800, 7 days a week, from 8 a.m. to 5 p.m. Central Standard Time with questions. 

Any adverse events or quality concerns relating to these products should be promptly reported to the FDA’s MedWatch program online, by mail, or by fax. Further guidance and resources for reporting product or facility issues are available through the FDA’s SmartHub system.