DermaRite recalls DermaKleen antiseptic lotion due to bacterial contamination with Burkholderia cepecia. Products sold in 800ml and 1000ml bag-n-box containers may pose health risks.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
DermaRite is recalling DermaKleen antiseptic lotion soap with Vitamin E that was found contaminated with bacteria Burkholderia cepecia. Using this product could lead to infections or health issues, especially for people with open wounds or compromised immune systems.
The lotion was contaminated with the bacteria Burkholderia cepecia, which can cause infections. This contamination occurred during manufacturing, potentially leading to health issues if the product is used on open wounds or broken skin.
People who own or use DermaKleen antiseptic lotion soap with Vitamin E (Chloroxylenol 0.2%) in 800ml or 1000ml bag-n-box containers are affected. Those with open wounds or weakened immune systems are at higher risk.
Check for DermaKleen antiseptic lotion soap with Vitamin E (Chloroxylenol 0.2%) in 800ml (27 fl. oz.) or 1000ml (34 fl. oz.) bag-n-box containers. The lot numbers and expiration dates are listed in the recall notice.
Identify the lot number and expiration date on the product label to confirm if it is recalled.
The product was found contaminated with bacteria Burkholderia cepecia, so it is not safe to use. DermaRite recommends stopping use and returning the product.
Contact DermaRite at 7777 West Side Avenue, North Bergen, NJ 07047 for instructions on returning the product.
Check the product label for lot numbers and expiration dates listed in the recall notice: 800ml containers have lot numbers like 30550A (exp. 7/2025) and 1000ml containers have lot numbers like 30586A (exp. 7/2025).
We’ve drafted a message you can send DermaRite to request your refund or repair — edit it as you like.
Subject: Recall D-0610-2025 — DermaRite DermaRite Hello, I own a DermaRite that is covered by recall D-0610-2025 from DermaRite. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.