DermaRite Industries’ DermaKleen antiseptic lotion soap is recalled nationwide after contamination with Burkholderia cepacia. The Class I recall covers 11,321 bag-in-box units sold nationwide. Consumers are urged to stop using the products and contact the company 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
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DermaKleen is a healthcare antiseptic lotion soap used for hand hygiene and skin cleansing in clinical and care settings. It is sold in healthcare facilities and possibly through distributors nationwide.
Contamination with Burkholderia cepacia can cause serious infections, particularly in vulnerable populations. This is a non-sterile product risk.
This recall is part of a broader pattern of microbial contamination recalls in non-sterile drug products.
Immediate stop-use is required for affected lots. Healthcare facilities may need to segregate or quarantine lots and implement infection-control measures. Financial impact includes batch recalls and potential replacement costs.
Check FDA recall page and manufacturer communications for lot and expiration details.
No specific refund timeline provided. Expect guidance in recall notices or direct communication from the manufacturer within weeks.
Retain packaging, lot numbers, expiration dates, and correspondence with the manufacturer for records
Brand: DERMAKLEEN or DermaKleen. Company: DermaRite Industries LLC. Form: Bag-in-box antiseptic lotion soap with vitamin E. Concentration: Chloroxylenol 0.2%. Pack sizes: 800 ml (27 fl oz) bag-n-box; 1000 ml (34 fl oz) bag-n-box. NDCs: 61924-092-27 and 61924-092-34. Lot numbers and expiration dates include multiple codes such as 30550A (Exp. 7/2025), 30670A, 30682A (Exp. 8/2025), 40025A (Exp. 1/2026), 40375A (Exp. 4/2026), 40427A, 40436A (Exp. 5/2026), 50068A (Exp. 1/2027), and batch 30586A/B, 30626A (Exp. 7/2025), 30628A, 30657A (Exp. 8/2025). Sold nationwide in the USA. Remains active as of
No specific injuries or incidents are described in the recall notice. The FDA enforcement page lists a Class I recall with contamination risk.
Not sure what to do next? Our guide walks you through the process step by step.
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