FDA Drugs recall ·
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0610-2025
- Date
- (initiated July 17, 2025)
- Company / brand
- DermaRite Industries, LLC
7777 W Side Ave, North Bergen, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 11,321 bag in boxes
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, Exp. Date 7/2025; 30628A, 30657A, Exp. Date 8/2025; 30741A, Exp. Date 7/2025; 30871A, Exp. Date 10/2025; 40002A, Exp. Date 12/2025; 40012A, Exp. Date 1/2026; 40301A, Exp. Date 3/2026; 40789 A, Exp. Date 9/2026; 50068B, Exp. Date 1/2027; 50144A, 50149A, Exp. Date 2/2027.
Distribution
Nationwide within the USA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0610-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.