Blaine Labs, Inc. is recalling 3 lot numbers of its Revitaderm® and Tridergel™ antiseptic wound care gel products after laboratory testing detected contamination with Lysinibacillus fusiformis, an environmental, spore-forming bacterium.
The Santa Fe Springs, California company announced the voluntary recall on April 7, 2026. The affected products — 1 oz. and 3 oz. bottles and tubes containing 0.1% Benzalkonium Chloride — were distributed exclusively to healthcare providers such as physician clinics nationwide. They were not sold in retail stores or online.
The 3 recalled lot numbers are BL3608, BL3435, and BL3525.
No adverse events have been reported to date.
Blaine Labs states that Lysinibacillus fusiformis is generally considered to have low pathogenicity in healthy individuals. However, the company warns that patients with open wounds, compromised skin barriers, or weakened immune systems may be at increased risk.
Higher-risk individuals include elderly individuals, people with diabetes, and immunocompromised patients. These patients could develop infections, skin irritation, or delayed wound healing. In severely immunocompromised individuals, infections may become severe and lead to life-threatening complications such as endocarditis or central nervous system infection.
Revitaderm® Wound Care Gel is identified by purple trim; Tridergel™ Wound Care is identified by light blue trim. The lot number and expiration date are printed on the bottom of 1 oz. bottles and imprinted along the crimp of 3 oz. tubes.
Healthcare providers with affected inventory should discontinue use immediately, segregate remaining stock, and contact Blaine Labs to arrange for return. Consumers with questions can call Blaine Labs at (800) 307-8818, Monday through Friday, 7:30 AM to 4:00 PM PST, or email Contact@blainelabs.com.
Adverse reactions may also be reported to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch.
Patients who were treated at a doctor’s office or clinic using any of these recalled lot numbers and who subsequently experienced wound infections, skin complications, or delayed healing may have legal options. A product liability attorney can advise on individual rights.