Quick Facts at a Glance
- Recall Date
- July 17, 2025
- Hazard Level
- HIGH
- Brands
- DERMAKLEEN, Dermarite Industries LLC
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, INFANTS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- DERMAKLEEN, Dermarite Industries LLC
- Product type
- Antiseptic Lotion Soap
- Model numbers
- Lot # 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 +5 more
- UPC codes
- 61924-092, 61924-092-08, 61924-092-01, 61924-092-34, 61924-092-27, 61924-092-11
- Sizes
- 800 ml bag-n-box, 1000 ml bag-n-box
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 17, 2025
Reported by FDA DRUG
September 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact DermaRite Industries, LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
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.
Why This Is Dangerous
Contamination with Burkholderia cepacia can cause serious infections, particularly in vulnerable populations. This is a non-sterile product risk.
Industry Context
This recall is part of a broader pattern of microbial contamination recalls in non-sterile drug products.
Practical Guidance
How to identify if yours is affected
- 2. Check expiration dates (7/2025 to 1/2027).
- 3. Confirm packaging type is bag-n-box 800 ml or 1000 ml.
Where to find product info
Check FDA recall page and manufacturer communications for lot and expiration details.
What timeline to expect
No specific refund timeline provided. Expect guidance in recall notices or direct communication from the manufacturer within weeks.
If the manufacturer is unresponsive
- Document all contact attempts
- Escalate to FDA/CMC if no response within 2-4 weeks
- Consider filing a consumer complaint with applicable agency
How to prevent similar issues
- Verify lot and expiration dates before stocking products
- Implement batch segregation in facilities
- Source from authorized distributors only
- Maintain a recall-ready inventory list
Documentation advice
Retain packaging, lot numbers, expiration dates, and correspondence with the manufacturer for records
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Product Details
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
Reported Incidents
No specific injuries or incidents are described in the recall notice. The FDA enforcement page lists a Class I recall with contamination risk.
Key Facts
- Bag-n-box packaging, 800 ml and 1000 ml
- Exp. dates listed from 7/2025 to 1/2027
- Nationwide distribution in USA
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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