DermaKleen — Class I drug recall D-0610-2025
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-0610-2025 |
|---|---|
| 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 | 11,321 bags |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia |
| NDC | 61924-0092-27, 61924-0092-34 |
| Expiration dates | 2025-07, 2025-08, 2025-10, 2025-12, 2026-01, 2026-03, 2026-04, 2026-05, 2026-09, 2027-01, 2027-02 |
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.
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-0610-2025. 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.