KleenFoam — Class I drug recall D-0612-2025
Ongoing recall by DermaRite Industries, LLC, reported 2025-09-10, distributed nationwide. Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacte
| Recall number | D-0612-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DermaRite Industries, LLC, North Bergen, NJ, United States |
| Recall initiated | 2025-07-17 |
| Classified | 2025-09-02 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 6,973 cartridges |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia |
| NDC | 61924-0093-34 |
| Lot numbers | 30705A, 30771A, 30920A, 40016A, 40303A, 40428A, 40505A, 41053A, 41053B, 41053C, 50017A |
| Expiration dates | 2025-08, 2025-09, 2025-10, 2026-01, 2026-04, 2026-05, 2026-06, 2026-12, 2027-01 |
Product
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
Reason for recall
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0612-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.