D-0163-2026 Class II Ongoing
FDA drug recall D-0163-2026 was initiated by DermaRite Industries, LLC on August 27, 2025 and is designated Class II. Reason for recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. The recall status is ongoing. Affected quantity: 7,736 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- November 26, 2025
- Initiation Date
- August 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,736 tubes
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.
Reason for Recall
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Distribution Pattern
Nationwide in the USA
Code Information
All lots on or before expiry date 08/2027