Antiseptic lotion soap recalled over contamination with Burkholderia cepacia
DermaRite DermaKleen Health Care Antiseptic Lotion Soap is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I. 11,321 bag-in-boxes are affected.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this Burkholderia cepacia contamination as Class I.
Plain-English summary
DermaKleen Health Care Antiseptic Lotion Soap with Vitamin E, containing chloroxylenol 0.2%, in 800 mL (27 fl oz) bag-in-box, NDC 61924-092-27, and 1000 mL (34 fl oz) bag-in-box, NDC 61924-092-34, from DermaRite Industries LLC of North Bergen, New Jersey, is being recalled. Affected lots include 30550A expiring 7/2025, 30670A and 30682A expiring 8/2025 and 40025A, with the full list in the recall notice. The recall covers 11,321 bag-in-boxes distributed nationwide.
The recall was issued for microbial contamination of a non-sterile drug product: the products were found to be contaminated with the bacteria Burkholderia cepacia. The FDA classified the action as Class I, its most serious category.
Healthcare facilities and consumers holding these lots should stop using the product and follow the manufacturer's instructions for return or disposal.
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 — Antiseptic
- Affected units
- 11,321
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.
Part of a larger recall action
This product is one of 4 recalled by DermaRite Industries, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · DermaRite Industries, LLC
See all →- ModerateMoisturizing skin cream recalled over contamination found at the manufacturing facility
FDA (Drugs) · 2025-11-26
- ModeratePetrolatum barrier ointment recalled over contamination found at the manufacturing facility
FDA (Drugs) · 2025-11-26
- ModerateAntiperspirant spray recalled over contamination found elsewhere at the facility
FDA (Drugs) · 2025-11-26
- ModerateSkin protectant ointment recalled over contamination found at its manufacturing facility
FDA (Drugs) · 2025-11-26
- ModerateLanolin skin protectant recalled over contamination found at the manufacturing site
FDA (Drugs) · 2025-11-26
Same hazard · microbial contamination
See all →- SevereMedtronic Recalls Grafton DBM Allografts Due to Donor Microbial Presence
FDA (Devices) · 2026-10-21
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateAntiseptic lotion soap recalled over contamination found at the manufacturing facility
FDA (Drugs) · 2025-11-26
- ModeratePerineal antiseptic recalled over contamination found at the manufacturing facility
FDA (Drugs) · 2025-11-26
- ModerateFoaming hand soap recalled over contamination found at the manufacturing facility
FDA (Drugs) · 2025-11-26
- ModerateAntimicrobial foam soap recalled over contamination found at the manufacturing facility
FDA (Drugs) · 2025-11-26
- ModerateNo rinse wash cream recalled over contamination found at the manufacturing facility
FDA (Drugs) · 2025-11-26
- HighDukal Recalls ZEE Antiseptic Wipes Due to Microbial Contamination
FDA (Drugs) · 2012-09-26