DermaRite Industries, LLC has issued a voluntary nationwide recall of specific lots of DermaKleen, Dermasarra, Kleenfoam, and Perigiene products due to contamination with Burkholderia cepacia. This bacterium poses significant health risks, particularly to immunocompromised individuals.
The recall affects products distributed across the United States and Puerto Rico. The company has not received reports of adverse events related to the recall, according to the recall notice.
Burkholderia cepacia, commonly found in soil and water, can cause serious infections. In healthy individuals with minor skin lesions, the contaminated products may lead to localized infections. However, in immunocompromised individuals, the infection could escalate to life-threatening sepsis, the company stated.
The recalled products include:
- DermaKleen, an over-the-counter antiseptic lotion soap with Vitamin E, is used for handwashing to reduce bacteria on the skin.
- Dermasarra, an external analgesic for temporary relief of itching from minor skin irritations such as dry skin, insect bites, detergents, or sunburn.
- Kleenfoam, an antimicrobial foam soap with Aloe Vera, is intended for handwashing in scenarios like diaper changes, assisting ill individuals, or before contact with patients under medical care.
- PeriGiene, an antiseptic cleanser for use in the perineal area.
Affected products include various lots of DermaKleen in 800ml and 1000ml bag-n-box formats, Dermasarra in 7.5oz containers, Kleenfoam in 1000ml containers, and PeriGiene in 7.5oz containers, with expiration dates ranging from July 2025 to February 2027. A complete list of lot numbers and product details is available on the U.S. Food and Drug Administration’s website.
DermaRite has instructed distributors and customers via email to inspect their inventory and destroy affected products according to their facility’s protocols. Consumers with concerns can contact Mary Goldberg at 973-569-9000, extension 104, Monday through Friday, 9 a.m. to 5 p.m. EST, or email [email protected].
Individuals experiencing issues potentially related to these products should consult their healthcare provider.
Adverse reactions or quality problems can be reported to the FDA’s MedWatch program online at www.fda.gov/medwatch/report.htm, by downloading a form at www.fda.gov/MedWatch/getforms.htm, or by calling 1-800-332-1088 to request a form for submission by mail or fax to 1-800-FDA-0178.