DermaRite Industries, LLC has announced a voluntary recall of several products due to microbial contamination with Burkholderia cepacia, which poses serious health risks.
The recall affects multiple lots of DermaKleen, DermaSarra, KleenFoam, and PeriGiene products distributed nationwide in the United States and Puerto Rico, the company said in a news release.
Burkholderia cepacia can cause life-threatening infections, particularly in immunocompromised people, according to the Centers for Disease Control and Prevention.
DermaRite has not received any reports of adverse events related to this recall.
DermaKleen is an over-the-counter antiseptic (OTC) lotion soap with Vitamin E, used for handwashing to decrease bacteria on the skin.
DermaSarra is an OTC external analgesic for temporary relief of itching due to minor skin irritations.
KleenFoam is an OTC antimicrobial foam soap with Aloe Vera for handwashing, especially after changing diapers or assisting ill individuals.
PeriGiene is an OTC antiseptic cleanser for use in the perineal area.
The recalled products have specific reorder numbers and lot numbers, with expiration dates ranging from July 2025 to January 2027.
The list can be found here.
DermaRite informed distributors and customers to examine their inventory and destroy affected products.
Consumers with questions can contact the company at 973-569-9000 extension 104 or by email. Adverse reactions or quality problems can be reported online to the FDA’s MedWatch Adverse Event Reporting program.
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