FDA Warns of Contamination Concerns in Over-the-Counter Drug Recall

The list of products includes Advil, Bayer, Advil, Tylenol, and more that were distributed by a Minneapolis-based company.

Empty medication store supplied with meds and prescription drugs for individuals. Pharmacy selling prescribed medicines, nutrients, antibiotics and relievers. Healthcare assistance initiative. DC Studio/Shutterstock

The Food and Drug Administration (FDA) said in multiple notices that numerous over-the-counter medications, including Bayer aspirin, Tylenol, Advil, Alka Seltzer, and more, are under recall by the agency due to conditions in a Minnesota distribution center.

Minneapolis-based Gold Star Distribution Inc. issued recalls for certain lots of Advil, Bayer aspirin, Claritin antihistamine, DayQuil Cold & Flu, Liquid DayQuil, Liquid NyQuil, NyQuil Cold & Flu, Children’s NyQuil Cold & Flu, Pepto Bismol, Pepcid Complete, Tylenol, Halls Cough Drops, and Tums.

A full list of the more than 800 items, including human food products, pet food, and cosmetics under recall by Gold Star can be found on a document posted on the FDA’s website.

The notices all said that the recalls were initiated over “insanitary conditions, including rodent exposure/activity in their distribution center.” While the recalls of the product are ongoing, Gold Star initiated the action on Dec. 26, 2025, and the FDA posted the notices on Jan. 14.

In the notices, the FDA said that the recalls were upgraded to Class II, or second out of a three-tier system, which the agency defines as a “situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Other products, which are not over-the-counter medications, that were distributed by Gold Star are also under recall, according to a slew of notices posted by the agency on Jan. 14.

Several types of Colgate toothpaste, Axe Body Spray in different varieties, Vaseline products, Lucky Ice mouthwash, Personal Care Vaporizing Chest Rub, Carmex products, Personal Care Ice Gel, and Swan White Clear Alcohol are under recall, according to the notices. The FDA also classified those as Class II for the same sanitary-related reason at the distribution center.

An FDA-issued news release from Gold Star about the recall in late December stated that bird and rodent feces were discovered at the facility. Affected products include medical devices, drugs, human food, pet food, and cosmetic products, the agency said. The products were distributed in more than 50 stores, nearly all of them in the Minneapolis-St. Paul area.

The reason for the recall, the company also said, is due to a “potential Salmonella contamination, presence of rodent and avian contamination, and insanitary conditions during the storage process.”

People who consume or handle the products could become sickened because of “adulteration from pests, including rodents, birds, and insects,” it said.

An FDA investigation discovered that Gold Star facilities harbored “rodent excreta, rodent urine, and bird droppings in areas where medical devices, drugs, human food, pet food, and cosmetic products were held,” according to the release.

No illnesses were reported when the recall notice was issued on Dec. 26.

“Consumers and retailers who purchased the affected products should destroy the products as soon as possible and verify such destruction by receipt provided to Gold Star,” the recall notice stated. “Products should not be shipped back to Gold Star under any circumstances. Gold Star will provide refunds upon request.”

Salmonella symptoms can include diarrhea, fever, vomiting, dehydration, and abdominal cramps, among others, federal health officials say. Signs and symptoms generally begin between six hours and six days after exposure and can last up to a week.

Although most people recover without medical treatment, the illness can be severe, especially for young children, older adults, and people with compromised immune systems.