Table of contents
- Latest DermaKleen Recall Updates
- October 27, 2025: FDA Issues Warning Letter to DermaRite
- September 8, 2025: DermaRite Writes to Customers
- August 27, 2025: DermaRite Expands the Recall
- August 8, 2025: DermaRite Announces Nationwide Recall
- July 16, 2025: DermaRite Starts the Recall
- Which DermaKleen Are Affected?
- Why Was DermaKleen Recalled?
- Reported Incidents, Injuries, or Illnesses
- What Should Consumers Do?
- Other Recalls, Warnings, or International Actions
- Legal Options
- Frequently Asked Questions
- Does Walmart Sell DermaRite Products?
- What Are the Symptoms of a Burkholderia Cepacia Infection?
- Did the FDA Take Action Against DermaRite?
- What Start Date Does the FDA Warning Letter Give for the Recall?
- What Is Burkholderia Cepacia?
DermaRite Industries recalled DermaKleen antiseptic lotion soap and other DermaRite skin products. The cause is Burkholderia cepacia contamination. The voluntary nationwide recall began July 16, 2025. DermaRite announced it August 8, 2025 and expanded it August 27, 2025.
The bacteria may cause serious and life-threatening infections. DermaRite had received no reports of adverse events when it announced the recall. No lawsuit, MDL or class action names DermaKleen. FDA posted the company’s notice as a public service.
Stop using any affected product. DermaRite’s recall contact is Sedgwick. Check your product’s lot number against the lot lists for each recalled DermaRite product.
Latest DermaKleen Recall Updates
October 27, 2025: FDA Issues Warning Letter to DermaRite
The FDA issued Warning Letter 320-26-09 to DermaRite Industries on October 27, 2025. FDA had inspected the company’s North Bergen, New Jersey plant from March 26 to April 8, 2025 [1].
FDA cites violations of current good manufacturing practice. It says they make the company’s drug products adulterated under section 501(a)(2)(B) of the FD&C Act.
September 8, 2025: DermaRite Writes to Customers
DermaRite sent customers a letter dated September 8, 2025. ABC News reported that the letter says the company’s wound care and nutritional products are not part of the recall [2].
ABC News also reported that the company has not said whether it has received any reports of adverse reactions to the recalled products.
August 27, 2025: DermaRite Expands the Recall
DermaRite expanded the recall on August 27, 2025 to include additional products and lots. FDA posted the notice on August 28, 2025 [3].
The company said it acted out of an abundance of caution. The notice also names Sedgwick as the new recall contact for consumers and customers.
August 8, 2025: DermaRite Announces Nationwide Recall
DermaRite announced the recall on August 8, 2025, a voluntary nationwide action covering DermaKleen, Dermasarra, KleenFoam and PeriGiene lots. FDA posted the notice on August 9, 2025, as a public service [4].
The company told distributors and customers by e-mail to examine inventory and destroy affected products. FDA labels the notice a company announcement and gives no classification.
July 16, 2025: DermaRite Starts the Recall
DermaRite initiated the voluntary recall on July 16, 2025, according to DermaRite’s expansion release [5]. The release describes the August 27 action as expanding that earlier recall.
Which DermaKleen Are Affected?
The recall covers these DermaKleen, Dermasarra, KleenFoam and PeriGiene products from the DermaRite recall notice [6]:
- DermaKleen 1000 ml bag-n-box, 10 per case, reorder 0092BB, lots 30586A, 30586B, 30626A, 30628A, 30657A, 30741A, 30871A, 40002A, 40012A, 40301A, 40789A, 50068B, 50144A and 50149A
- DermaKleen 800 ml bag-n-box, 12 per case, reorder 0090BB, lots 30550A, 30670A, 30682A, 40025A, 40375A, 40427A, 40436A and 50068A
- Dermasarra 7.5 oz, 24 per case, reorder 00188, lot 40187.2
- KleenFoam 1000 ml, 6 per case, reorder 0093F, lots 30705A, 30771A, 30920A, 40016A, 40303A, 40428A, 40505A, 41053A, 41053B, 41053C and 50017A
- PeriGiene 7.5 oz, 48 per case, reorder 00198, lots including 31013A, 40345A, 40355A, 40571A, 40580A, 40587A and 40591A
- The August 27 expansion lists 4-N-1, DermaCerin, DermaFungal, DermaKleen, DermaMed, DermaSarra, Gel Rite, Hand E Foam, KleenFoam, Lantiseptic, PeriGiene, PeriGuard, Renew Dimethicone, Renew Periprotect, Renew Skin Repair and UltraSure
The FDA warning letter says the August 27 expansion covers all lots of all products that contain water. ABC News reports that impacted products have expiration dates ranging from July 2025 to August 2027.
The products went to distributors and customers nationwide and in Puerto Rico. Newsweek reports that Walmart’s list names select Sam’s Club locations [7].
Why Was DermaKleen Recalled?
DermaKleen was recalled because of microbial contamination identified as Burkholderia cepacia. DermaRite’s risk statement says infections are a risk for immunosuppressed people or those who care for them.
The FDA warning letter gives more detail. Initial tests failed for total aerobic microbial count. Retained samples failed for Burkholderia cepacia. That led to the recall.
For DermaKleen Lot 40375A, the first count was “too numerous to count.” The company sent a second sample to a contract lab and got passing results. It then released the batch. FDA calls this “testing into compliance.”
For DermaKleen Lot 9-40545, an assay for the active ingredient chloroxylenol was out of specification. A retest also failed and the firm released the batch. FDA says the certificate of analysis did not reflect the actual results.
Reported Incidents, Injuries, or Illnesses
DermaRite had not received any reports of adverse events related to the recall as of its August 8, 2025 notice. Neither the August 27 notice nor the September 8 letter gives an adverse-event count.
The company says healthy people with minor skin lesions may get local infections. In immunocompromised people, the infection could reach the blood stream. That could lead to life-threatening sepsis.
A report of illness does not prove that the product caused it. ABC News, citing the CDC, says people who are immunocompromised face a higher risk of infection. So do people with chronic lung conditions such as cystic fibrosis.
What Should Consumers Do?
Take these steps if you own or used a DermaRite skin product:
- Stop using any affected product and check its lot number against the lot lists above.
- If you hold inventory, examine it and destroy affected products as the notice directs.
- Call Sedgwick, DermaRite’s recall contact, at 888-943-5190, Monday through Friday, 8:00 am to 5:00 pm EST, or email dermarite5186@sedgwick.com.
- Contact a physician about any problem that may relate to the product, such as a skin infection or signs of sepsis.
- Report adverse reactions to FDA MedWatch at www.fda.gov/medwatch/report.htm or 1-800-332-1088.
- Keep photos of the label and lot number, purchase receipts, the product itself and notes on your symptoms and dates.
Other Recalls, Warnings, or International Actions
The August 27, 2025 expansion widened the recall from four brands to a DermaRite line of hand sanitizers, cleansers, skin protectants and a deodorant.
DermaRite’s own August 27 release also lists 3-N-1, Clean-N-Free, DermaDaily, DermaKlenz, DermaRain, DermaSyn, DermaVantage and DermaVera, on top of the 16 products in FDA’s copy of the release.
Legal Options
No lawsuit, MDL or class action over DermaKleen or the DermaRite recall has been filed. A recall does not automatically establish a right to compensation.
If you believe a recalled DermaRite product harmed you, keep your records. You may speak with a lawyer about product liability claims.
Those claims depend on the facts and the law of each state. The Dermasarra recall page covers the same DermaRite recall.
Frequently Asked Questions
Does Walmart Sell DermaRite Products?
Walmart says some recalled DermaRite products were sold at select Sam’s Club stores in 14 states, as Newsweek reported. Its list names clubs in California, Georgia, Illinois, Louisiana, Michigan, Minnesota, Missouri, Nebraska, New York, Ohio, Oklahoma, Texas, Virginia and West Virginia.
What Are the Symptoms of a Burkholderia Cepacia Infection?
The symptoms of a Burkholderia cepacia infection can include respiratory issues, fever or fatigue, according to the CDC as reported by ABC News. Some infected people have no symptoms. The bacteria can also resist antibiotics.
Did the FDA Take Action Against DermaRite?
The FDA took action against DermaRite in its warning letter. The letter finds that DermaSeptin, Lantiseptic Moisture Shield, DermaMed, DermaFungal and PeriGiene are unapproved new drugs and misbranded under section 502(ee), and finds DermaMed misbranded on other grounds too.
What Start Date Does the FDA Warning Letter Give for the Recall?
The FDA warning letter gives July 17, 2025 as the start date of the DermaRite recall. The company notices say July 16, 2025. The August 27 expansion notice gives the same July 16 date.
What Is Burkholderia Cepacia?
Burkholderia cepacia, also called B. cepacia or Bcc, is a bacteria that often spreads through soil and water sources, in addition to contaminated surfaces and products and through person-to-person contact, according to the CDC.