DermaRite Industries has voluntarily recalled several lots of its DermaKleen, DermaSarra, KleenFoam, and PeriGiene soaps and cleansers after contamination with Burkholderia cepacia, a bacterium that can cause life-threatening sepsis in immunocompromised people.
Reason for the recall
August 8, 2025, saw the announcement of DermaRite Industries voluntarily recalling four OTC personal care items, DermaKleen, DermaSarra, KleenFoam, and PeriGiene, from the market after the products tested positive for the Burkholderia cepacia complex in routine tests. No adverse events have yet been reported, but the company chose to recall the product “in an abundance of caution” for the benefit of susceptible people: that is, the patients currently residing in hospitals or long-term care facilities.
Contamination and sepsis risk
Burkholderia cepacia is a bacterium widespread in soil and water, typically of low risk to healthy individuals. Its introduction, however, into products designed for application on skin-moreso on broken skin-may cause localized infections that might enter the bloodstream and, hence, into sepsis, which can be fatal. Immunocompromised persons undergoing chemotherapy and those with chronic illnesses are therefore at greatest risk of sustaining severe infections.
Products and batches involved
DermaRite has identified the exact lots affected by the recall and notified distributors to withdraw all inventories urgently. Consumers should check their product packaging for the following information and should not use any lot numbers that match:
- DermaKleen 1000 ml bag-n-box (10/case), Reorder #0092BB
- Lot Numbers: 30586A, 30586B, 30626A, 30628A, 30657A, 30741A, 30871A, 40002A, 40012A, 40301A, 40789A, 50068B, 50144A, 50149A
- DermaKleen 800 ml bag-n-box (12/case), Reorder #0090BB
- Lot Numbers: 30550A, 30670A, 30682A, 40025A, 40375A, 40427A, 40436A, 50068A
- DermaSarra 7.5 oz bottle (24/case), Reorder #00188
- Lot Number: 40187.2
- KleenFoam 1000 ml foam (6/case), Reorder #0093F
- Lot Numbers: 30705A, 30771A, 30920A, 40016A, 40303A, 40428A, 40505A, 41053A, 41053B, 41053C, 50017A
- PeriGiene 7.5 oz cleanser (48/case), Reorder #00198
- Lot Numbers: 31013A, 40345A, 40355A, 40571A, 40580A, 40587A, 40591A, 40870.1, 40877.1, 41093A, 50072A, 50079A
What consumers should do
Anyone who purchased or is using any of the recalled products should:
- Stop use immediately: Discontinue use of affected products.
- Consult healthcare providers: Seek medical advice if experiencing redness, swelling, fever, or other signs of infection after product use.
- Report adverse events: File a report via FDA’s MedWatch program online, by mail, or by fax if experiencing health issues potentially linked to these products.
- Dispose properly: Do not pour the products down drains; follow local regulations for disposal of contaminated materials.
The FDA is working closely with DermaRite to ensure that all affected products are taken off the distribution networks and store shelves, and has instructed certain distributors and healthcare facilities to quarantine and destroy all recalled lots. Any consumer questions should be directed to DermaRite at 973-569-9000 ext. 104, Monday-Friday, 9 a.m.-5 p.m. ET, or via email at [email protected]. Ongoing monitoring and enhanced environmental controls at manufacturing sites are underway to prevent future contamination incidents.
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