DermaRite Industries, LLC: Drug Recall
Recall #D-0163-2026 · 08/27/2025
Class II: Risk
Recall Details
- Recall Number
- D-0163-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- DermaRite Industries, LLC
- Status
- Ongoing
- Date Initiated
- 08/27/2025
- Location
- North Bergen, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,736 tubes
Reason for Recall
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Product Description
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Distribution Pattern
Nationwide in the USA
Other Recalls by DermaRite Industries, LLC
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.