Tridergel, Revitaderm Wound Gel Recall Issued Over Bacterial Contamination: FDA

Contaminant has been linked to a risk of sepsis, ulcers and endocarditis, in addition to blood, skin and central nervous system infections.

Three lots of Blaine Labs wound care gel have been recalled after testing discovered Lysinibacillus fusiformis, a type of environmental bacteria that could cause serious infections.

The U.S. Food and Drug Administration (FDA) announced the Blaine Labs wound care gel voluntary recall on April 8, affecting two brands of wound care gel, Revitaderm and Tridergel. Both brands are manufactured by Blaine Labs.

Wound care gel is an antibacterial topical treatment designed to help injuries heal more quickly. The gel is advertised to assist in the prevention of infections for minor cuts, scrapes and burns by providing a protective, moist layer over the wound. The gel contains 0.1% benzalkonium chloride, an ammonia-based chemical that also helps kill bacteria.

Lysinibacillus fusiformis, the contaminant identified in Revitaderm and Tridergel products, is a bacteria commonly found in soil and water. It can survive in extreme conditions and may pose a particular risk to patients with open wounds, where it can interfere with normal healing.

While the bacteria typically does not cause severe illness, infections have been linked to sepsis, blood infections, ulcers and skin conditions, especially among individuals with weakened immune systems. In more serious cases, the bacteria may lead to life-threatening complications, including endocarditis or central nervous system infections.

Blaine Labs Wound Gel Recall

The Blaine Labs recall affects three lots of Revitaderm and Tridergel sold in 1 oz. and 3 oz. bottles and tubes. Revitaderm Wound Care Gel can be identified by its purple trim and Tridergel Wound Care can be identified by its light blue trim.

The products were distributed nationwide directly to healthcare providers and were not available for retail or online sale. The 1 oz. bottle has two cap configurations: twist or a long pointy cap. The expiration date and lot number is located on the bottom of the bottle. The 3 oz. tube contains the lot number and expiration date imprinted along the crimp at the top of the tube.

Blaine Labs has indicated that no infections or illnesses have been reported in connection with the recall, which was announced after routine testing identified the bacteria.

The recall notice recommends doctors and healthcare offices remove affected products and stop using them immediately. Additionally, customers should contact Blaine Labs at 800-307-8818 with any questions and to arrange for a return.

Wound Care Contamination Concerns

Recent recalls and lawsuits have raised serious questions about the safety and sterility of certain wound care gels and solutions, with multiple reports linking contaminated products to severe infections and life-threatening complications.

Last year, a Medihoney Wound Gel lawsuit was filed after the FDA issued at least three recalls for certain lots of the product. That claim alleged the gel was not sterile, leading to a severe infection, hospitalization and kidney failure for the plaintiff.

A number of other sterile solution lawsuits have also been filed by other individuals who claim they suffered serious infections and life-threatening complications as the result of compromised lots of sterile water and saline solutions.

In July 2025, a Nurse Assist lawsuit alleged that compromised sterile water caused an infection that progressed to gangrene and necrotizing fasciitis, ultimately requiring amputation of the plaintiff’s right leg.

A similar lawsuit was also filed against Amazon earlier this year, claiming SteriCare sterile water products sold through the platform were contaminated, leading to infection and the amputation of a consumer’s foot.

As a result of these claims and others like them, product liability attorneys are currently investigating infection and injury claims linked to breaches of sterility among certain kinds of wound care products.

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