DermaRite Recalls Over 20 Skin-Care Products Amid Sepsis Risk

DermaRite Industries has voluntarily recalled more than 20 of its skin-care and hygiene products nationwide after tests detected potential Burkholderia cepacia contamination, which can cause life-threatening sepsis in immunocompromised patients, the New Jersey manufacturer announced on September 11 2025.

The recall affects multiple hand soaps, lotions, cleansers and antiseptic products distributed across the United States and Puerto Rico. DermaRite expanded its initial August recall to include additional lots after routine internal testing revealed the presence of the bacteria, prompting the action “out of an abundance of caution” to protect patient safety.

Contamination Concerns and Health Risks

Burkholderia cepacia complex organisms thrive in moist environments and can lead to local skin infections in healthy individuals with minor wounds. In immunosuppressed patients-such as those undergoing chemotherapy or living with cystic fibrosis-the bacteria may enter the bloodstream, potentially causing severe or fatal sepsis. The Centers for Disease Control and Prevention classifies B. cepacia as an opportunistic pathogen with notable antibiotic resistance.

Affected Products and Lot Numbers

Products in the expanded recall include, but are not limited to:

  • DermaKleen antiseptic lotion soaps
  • KleenFoam antimicrobial foam soaps
  • DermaSarra external analgesics
  • 4-N-1 no-rinse wash creams
  • PeriGiene antiseptic cleansers
  • Renew Skin Repair creams

Full product descriptions, lot numbers and expiration dates are available on DermaRite’s website and the FDA recall notice.

Corporate Response and Next Steps

DermaRite has notified distributors and health-care facilities by email to immediately quarantine and destroy all affected inventory per facility protocols. Customers and institutions with questions can contact recall administrator Sedgwick at 888-943-5190, Monday-Friday, 8 a.m.-5 p.m. EST, or via email at [email protected].

Consumers who have used any of the recalled products and experienced adverse effects are urged to consult their health-care provider and report incidents to the FDA’s MedWatch program at www.fda.gov/medwatch/report.htm or by mail/fax using Form 3500.

Monitoring and Prevention

The FDA is working alongside DermaRite to monitor reports of contamination and ensure no further products are affected. Health-care facilities and retailers are advised to check lot numbers against the official recall list and remove any matching products from use immediately. Continuous surveillance and strict adherence to infection-control protocols remain paramount to safeguarding vulnerable patient populations.