CLASS I ONGOING Drug recall · Reported 10 Sep 2025 · FDA Enforcement Report
KleenFoam, Antimicrobial Foam Soap with Aloe Vera recalled
DermaRite Industries is recalling KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) per cartridge, distributed nationwide in the US. The recall was initiated on 17 Jul 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0612-2025
- FDA event ID
- 97277
- Recalling firm
- DermaRite Industries, North Bergen, NJ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 17 Jul 2025
- FDA classified
- 2 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 17 Jul 2025 | Recall initiated by company | |
| 2 Sep 2025 | Classified by FDA | +47 days |
| 10 Sep 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
Where it was distributed
Nationwide within the USA
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Which lots are affected?
Lot #: 30705A, Exp. Date 8/2025; 30771A, Exp. Date 9/2025; 30920A, Exp. Date 10/2025; 40016A, Exp. Date 1/2026; 40303A, Exp. Date 4/2026; 40428A, Exp. Date 5/2026; 40505A, Exp. Date 6/2026; 41053C, 41053A, 41053B, Exp. Date 12/2026, 50017A, Exp. Date 1/2027.
Where was it sold?
Nationwide within the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 97277This product is part of a recall event; the main page for the event is PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) recalled | DermaRite Industries | Sterility | Nationwide | |
| CLASS I | DermaSarra, External Analgesic, (Camphor 0.5%) recalled | DermaRite Industries | Sterility | Nationwide | |
| CLASS I | DermaKleen, Health Care Antiseptic Lotion Soap recalled | DermaRite Industries | Sterility | Nationwide |
More recalls from DermaRite Industries
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%) recalled | DermaRite Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | 4-N-1 Skin Protectant, No Rinse Wash Cream recalled | DermaRite Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | McKesson Skin Protectant, Lanolin recalled by DermaRite IndustriesSkin Protectant With Lanolin | DermaRite Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lantiseptic, Dry Skin Therapy, Lanolin recalled by DermaRite Industries | DermaRite Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Renew Skin Repair Cream, Dimethicone recalled by DermaRite Industries | DermaRite Industries | Manufacturing (CGMP) Deviations | Nationwide |