A Southern California wound care maker has pulled several lots of its doctor-dispensed gels from clinics across the country after tests turned up an environmental bacterium, according to federal regulators. The voluntary recall covers Revitaderm and Tridergel in 1-ounce bottles and 3-ounce tubes that were shipped to medical offices nationwide, and customers have been told to stop using any affected lots right away. Blaine Labs is calling the move precautionary and says it has not received any reports of patients being harmed so far.
What the FDA found
According to the FDA, Blaine Labs notified regulators on April 7 that lab tests on samples of its wound gels had come back positive for Lysinibacillus fusiformis. The agency posted the company’s voluntary recall on April 8.
The recall notice describes Lysinibacillus fusiformis as an environmental, spore-forming bacterium that can act as an opportunistic pathogen in people with open wounds or weakened immune systems. Regulators say the recall was triggered as a precaution after microbial contamination was detected in tested product samples.
Which lots are affected
The recall targets three specific lot numbers: BL3608 (expires 07/01/28), BL3435 (expires 11/06/26), and BL3525 (expires 08/07/27). The codes are printed on the bottoms of bottles or stamped into the crimps at the ends of tubes, as reported by PIX11.
Blaine Labs has told customers that these products were distributed only through physician offices around the country and were not sold in retail stores or online. The company says it is reaching out directly to its customers and is setting up returns for product that has not yet been dispensed.
Who is most at risk
The FDA warns that people with open wounds, those who are immunocompromised, patients with poorly controlled diabetes, and young children could face greater risk of infection or delayed healing if contaminated product is used. Medical case reports have rarely linked Lysinibacillus species to bloodstream and wound infections in vulnerable patients, which is part of what has regulators on alert.
The gels are marketed as topical antiseptics for first-aid use and to support healing of minor cuts, scrapes, burns, ulcers and post-surgical sites, according to product labeling on DailyMed.
What to do if you have these gels
Clinics and healthcare providers are being told to immediately stop using and stop distributing any Revitaderm or Tridergel products with the affected lot numbers. Any remaining stock should be pulled from circulation and kept separate from other inventory, then returned to the company.
Blaine Labs lists a customer hotline and email address for arranging returns. Anyone who experiences possible side effects or infections after using the gels is urged to report them to the FDA’s MedWatch program using the instructions in the recall notice via FDA MedWatch.
Bottom line
Regulators say this recall is a precautionary move while Blaine Labs works to pull potentially affected product out of circulation, and the company has told authorities it has not received any reports of adverse events so far. Clinics that stock physician-supplied wound care products are being advised to comb through their shelves for the listed lot numbers and follow the return steps outlined by Blaine Labs and the FDA.
