FDA warns products may be contaminated with Burkholderia cepacia bacteria
of ConsumerAffairsAugust 12, 2025
FDA warns products may be contaminated with Burkholderia cepacia bacteria
Four brands of hand soap, lotion, and perineal cleanser affected in nationwide recall
Infections pose heightened danger to immunocompromised patients
DermaRite, a manufacturer of skincare, wound care, and infection control products widely used in healthcare settings, is recalling select lots of hand soap, lotion, and an intimate antiseptic cleanser after tests found possible contamination with Burkholderia cepacia bacteria. The recall, conducted in cooperation with the U.S. Food and Drug Administration (FDA), affects four of the companys brands:
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DermaKleen antiseptic lotion soap
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DermaSarra pain-relieving cream
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KleenFoam antimicrobial foam soap
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PeriGiene antiseptic perineal cleanser
The affected products were distributed across the United States and Puerto Rico and can be identified by reorder numbers 0092BB, 0090BB, 00188, 0093F, and 00198, along with lot codes and expiration dates published by the FDA.
According to the Centers for Disease Control and Prevention (CDC), Burkholderia cepacia is commonly found in soil and water and can cause serious respiratory infections, particularly in people with cystic fibrosis, chronic lung disease, or compromised immune systems. While healthy individuals face minimal risk, use of contaminated products on open skin lesions could result in localized infections, and in vulnerable patients, the bacteria may spread to the bloodstream, potentially causing life-threatening sepsis.
DermaRite says it has not received any reports of adverse events linked to the recalled lots. The company has advised distributors and healthcare customers to review their inventories and destroy affected products following facility procedures. Consumers with recalled items should stop using them immediately and contact their healthcare provider if they have concerns.
Questions about the recall can be directed to voluntary.action@dermarite.com, and adverse reactions can be reported to the FDAs MedWatch Adverse Event Reporting program.
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