DermaRite Recalls Four Skin Care Products Over Burkholderia cepacia Contamination Risk
Key Takeaways
DermaRite Industries has annoucned the recall of four antiseptic and analgesic products nationwide due to Burkholderia cepacia contamination.
The company says the bacterium poses severe infection risks to immunocompromised individuals, even potentially evolving to sepsis.
No adverse events have been reported to date.
DermaRite Industries has issued a nationwide recall of four over-the-counter antiseptic and analgesic products after tests detected contamination with Burkholderia cepacia complex (BCC), according to a statement released by the U.S. Food and Drug Administration (FDA)
According to a press release, the recall applies to specific lots of DermaKleen® Antiseptic Lotion Soap with Vitamin E, DermaSarra® External Analgesic, KleenFoam® Antimicrobial Foam Soap with Aloe Vera, and PeriGiene® Antiseptic Cleanser. The affected products have been distributed throughout the United States and Puerto Rico. Burkholderia cepacia complex, according to the statement, poses a threat to immunocompromised individuals, where infections can progress from localized skin areas to bloodstream infection and even potentially life-threatening sepsis. No adverse events have been reported in connection with the recalled lots.
The following products were included in the recall:
DermaKleen®: Antiseptic lotion soap for handwashing to reduce bacteria on the skin.
DermaSarra®: External analgesic for temporary relief of itching from minor skin irritations including insect bites, dry skin, detergent exposure, and sunburn.
KleenFoam®: Antimicrobial foam soap for handwashing, especially after assisting ill individuals or before contact with patients under medical care.
PeriGiene®: Antiseptic cleanser for the perineal area.
The statement said that consumers are advised to stop using the affected products immediately and follow facility protocols for destruction of inventory. Individuals experiencing symptoms they think may be related to use of the product(s) are advised to contact a healthcare provider.
DermaRite instructed customers to identify, quarantine, and destroy affected lots. Health care professionals, patients, and consumers are encouraged to report adverse events to the FDA MedWatch Safety Information and Adverse Event Reporting Program.
Source: FDA recall statement and summary. August 11, 2025.