DermaRite Industries LLC recalled 11,321 bags of DermaKleen antiseptic lotion soap on July 17, 2025. The product, contaminated with Burkholderia cepacia, poses a serious health risk. Consumers should stop using the product immediately and contact health providers for guidance.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Consumers and healthcare providers should stop using this product immediately. Contact DermaRite Industries, LLC or your healthcare provider for guidance. Notification method: Letter
The recalled DermaKleen antiseptic lotion soap is available in 800 ml (27 fl. oz.) and 1000 ml (34 fl. oz.) bag-n-boxes. The affected NDC numbers are 61924-092-27 and 61924-092-34. The products were distributed nationwide.
The product contains Burkholderia cepacia, a bacteria that can cause serious infections, particularly in individuals with weakened immune systems. The contamination classifies the recall as Class I, indicating a high level of risk.
There have been no reported injuries related to this contamination. However, Burkholderia cepacia can lead to significant health complications.
Consumers should stop using the product immediately. Contact DermaRite Industries, LLC or your healthcare provider for further guidance. Notifications have been sent via letter.
For more information, contact DermaRite Industries at 1-800-XXX-XXXX or visit their website at www.dermarite.com.
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