DermaKleen Health Care Antiseptic Lotion Soap Recalled for Bacterial Contamination
DermaKleen Health Care Antiseptic Lotion Soap products have been recalled due to contamination with Burkholderia cepacia bacteria. The FDA classified this as a Class I recall affecting approximately 11,321 units distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as Severe (4) due to FDA Class I classification. Class I designation indicates a reasonable probability that use of the contaminated product could cause serious adverse health consequences or death. Although no illnesses have been reported as of the recall announcement, the FDA's assessment of serious risk determines the severity level.
Plain-English summary
DermaKleen Health Care Antiseptic Lotion Soap with Vitamin E, manufactured by DermaRite Industries LLC, is being recalled due to contamination with Burkholderia cepacia bacteria. The contamination was discovered in the non-sterile drug product. Approximately 11,321 units in two sizes were affected: 800 ml (27 fl. oz.) and 1000 ml (34 fl. oz.) bag-in-box packages.
The affected products were distributed nationwide across the United States. Multiple lot numbers are implicated, with expiration dates ranging from July 2025 through January 2027. The FDA classified this recall as Class I, which applies to situations where there is a reasonable probability that the use of the defective product will cause serious adverse health consequences or death.
Consumers and health care facilities with affected units should verify their lot numbers and expiration dates against the recall notice. For questions about affected products, contact DermaRite Industries, LLC or the FDA.
The recalled product
- Product
- DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- microbial-contamination
- burkholderia-cepacia
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot # and Expiration Date: a) 30550A
- Exp. Date 7/2025
- 30670A
- 30682A
- Exp. Date 8/2025
- 40025A
- Exp. Date 1/2026
- 40375A
- Exp. Date 4/2026
- 40427A
- 40436A
- Exp. Date 5/2026
- 50068A
- Exp. Date 1/2027. b)30586A
- 30586B
- 30626A
- 30628A
- 30657A
- 30741A
- 30871A
Distribution
Distributed nationwide across the United States.
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