DermaRite Industries, LLC announced a voluntary nationwide recall of four over-the-counter healthcare products on August 8, 2025, due to microbial contamination identified as Burkholderia cepacia. The recall affects individual lots of DermaKleen, DermaSarra, KleenFoam, and PeriGiene products distributed throughout the United States and Puerto Rico.
Serious Health Risks Identified
The contamination poses significant health risks, particularly for vulnerable populations. According to the company's risk statement, Burkholderia Cepacia Complex in these products may result in serious and life-threatening infections. The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals.
In healthy individuals with minor skin lesions, the use of the product will more likely result in local infections. However, in immunocompromised individuals, the infection is more likely to spread into the bloodstream, leading to life-threatening sepsis.
Recalled Products and Their Uses
The recall encompasses four distinct product lines, each serving different healthcare purposes:
DermaKleen is an OTC healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.
DermaSarra is an OTC external analgesic indicated for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents, and sunburn.
KleenFoam is an OTC antimicrobial foam soap with Aloe Vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.
PeriGiene is an OTC antiseptic cleanser indicated for use in the perineal area.
Company Response and Consumer Actions
To date, DermaRite has not received any reports of adverse events related to this recall. The company has proactively notified its distributors and customers by email to immediately examine available inventory and destroy all affected products in accordance with each facility's process.
Consumers with questions regarding this recall can contact Mary Goldberg at 973-569-9000 x104 Monday through Friday, 9:00 am – 5:00 pm EST or email voluntary.action@dermarite.com.
The company advises consumers to contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.
Regulatory Oversight
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm, by regular mail, or by fax to 1-800-FDA-0178.
