Table of contents
- Latest KleenFoam Recall Updates
- September 8, 2025: DermaRite Posts a Customer Letter
- August 27, 2025: DermaRite Expands the Recall
- August 9, 2025: FDA Posts the Recall Notice
- August 8, 2025: DermaRite Announces the Recall
- Which KleenFoam Products Are Affected?
- Why Was KleenFoam Recalled?
- Reported Incidents, Injuries, or Illnesses
- What Should Consumers Do?
- Other Recalls, Warnings, or International Actions
- Legal Options
- Filing Deadlines
- Frequently Asked Questions
- Is There a KleenFoam Recall Lawsuit?
- What Are the Symptoms of a Burkholderia Cepacia Infection?
- How Can I Tell If My KleenFoam Is Part of the Recall?
- What Is KleenFoam Used For?
KleenFoam antimicrobial foam soap is part of a voluntary nationwide recall by DermaRite Industries. DermaRite announced the recall on August 8, 2025, and the FDA posted it on August 9, 2025.
The recall covers individual lots because of Burkholderia cepacia complex contamination, which may result in serious and life-threatening infections. DermaRite expanded the recall on August 27, 2025.
Stop using affected KleenFoam, check your lot number and ask a physician about any health problem. No lawsuit, class action or MDL has been filed over KleenFoam.
Latest KleenFoam Recall Updates
September 8, 2025: DermaRite Posts a Customer Letter
DermaRite posted a letter to customers. It says restoring full product availability is its highest priority. It also says wound care and nutritional products are not part of the recall [1].
August 27, 2025: DermaRite Expands the Recall
On August 27, 2025, DermaRite added more products and lots to the recall, as TODAY reported [2]. The expansion includes KleenFoam 1000ml, 6/case, with expiration in August 2027.
The company says it acted out of an abundance of caution. The expansion covers KleenFoam and other DermaRite lines, so check the lots against the lists below.
August 9, 2025: FDA Posts the Recall Notice
The FDA posted DermaRite’s company announcement of the recall on August 9, 2025 [3]. The notice covers individual lots of DermaKleen, DermaSarra, KleenFoam and PeriGiene.
The notice carries the FDA’s statement that it endorses neither the product nor the company. The FDA lists the product type as drugs.
August 8, 2025: DermaRite Announces the Recall
DermaRite announced a voluntary nationwide recall of individual lots on August 8, 2025 [4]. The reason given was Burkholderia cepacia contamination.
DermaRite told distributors and customers by e-mail to check their inventory and destroy all affected products. The recalled products were distributed nationwide in the United States and in Puerto Rico.
Which KleenFoam Products Are Affected?
The recall covers KleenFoam antimicrobial foam soap with Aloe Vera, made by DermaRite, and consumers who used or handled lots from the original recall or the August 27 expansion may be affected. These are the recalled products and lots:
- KleenFoam 1000ml, 6/case, with the reorder number 0093F, in the original recall
- Original lots 30705A, 30771A, 30920A, 40016A, 40303A, 40428A, 40505A, 41053A, 41053B, 41053C and 50017A
- The August 27 expansion adds KleenFoam 1000ml, 6/case, expiring in August 2027.
Why Was KleenFoam Recalled?
KleenFoam was recalled because of microbial contamination identified as Burkholderia cepacia complex, according to DermaRite’s own announcement. DermaRite calls the action a voluntary recall of individual lots.
DermaRite’s risk statement says healthy people with minor skin lesions are more likely to get local infections. In immunocompromised people, the infection is more likely to spread into the blood.
That can lead to life-threatening sepsis. The company adds that immunosuppressed people, or those caring for them, may use the products.
Reported Incidents, Injuries, or Illnesses
DermaRite had no adverse event reports tied to the recall when it issued its notice. See a physician if you have symptoms after using KleenFoam.
A recall notice does not show that anyone became ill from KleenFoam. Reports are also not proof that a product caused an illness.
TODAY, citing the CDC, says Burkholderia cepacia infection is a greater risk for people with cystic fibrosis or other chronic lung disease.
What Should Consumers Do?
Take these steps if you own or have used KleenFoam from the recalled lots:
- Stop using KleenFoam from the recalled lots.
- Check your product’s lot number against the lots listed above.
- Watch for fever, fatigue or a respiratory infection. Contact a physician or healthcare provider about any problem that may be related to using the product.
- Report adverse reactions or quality problems to the FDA’s adverse event reporting program at www.fda.gov/medwatch/report.htm or 1-800-332-1088.
- Call 888-943-5190 (Monday through Friday, 8:00 am to 5:00 pm EST) or email dermarite5186@sedgwick.com, the recall contact in DermaRite’s August 27 notice.
- Use 973-569-9000 x104 or voluntary.action@dermarite.com, the contacts in the original August 8 notice, if you need them.
Other Recalls, Warnings, or International Actions
The expanded recall also covers other DermaRite lines. They include DermaCerin, DermaFungal, DermaMed, Gel Rite, Lantiseptic and UltraSure. Their expiration dates are on or before August 2027.
Separate pages cover the DermaKleen recall, the DermaSarra recall and the PeriGiene recall, each with its own lots and details.
Legal Options
No case over KleenFoam is pending, so there is nothing to join. A recall does not by itself show that anyone is liable or eligible for compensation.
People who used a recalled product and became ill may ask a lawyer how their facts fit state law and their own circumstances.
Filing Deadlines
State law sets the deadline to file a claim. The time you have depends on where you live and when the illness or injury and its diagnosis happened. Missing the time limit can end a claim, even with strong facts.
Frequently Asked Questions
Is There a KleenFoam Recall Lawsuit?
There is no KleenFoam recall lawsuit to join yet. DermaRite is running the recall voluntarily, with the knowledge of the FDA, and a recall alone does not decide who may be liable for an illness.
What Are the Symptoms of a Burkholderia Cepacia Infection?
The symptoms of a Burkholderia cepacia infection include respiratory infections, fever and fatigue, says TODAY, citing the CDC. Ask a physician if you are unsure about any symptom.
How Can I Tell If My KleenFoam Is Part of the Recall?
Compare the lot number, expiration date and size of your KleenFoam with the recalled lots to see if it is part of the recall. Check the reorder number too. If nothing matches, ask the recall contact.
What Is KleenFoam Used For?
KleenFoam is used for handwashing to decrease bacteria on the skin. The FDA notice lists use after changing diapers, after assisting ill people, or before contact with a person under medical care. It is an over-the-counter foam soap.