FDAFDA · Food and drugs·Recall number D-0163-2026
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.
Published November 26, 2025 · Recall initiated: August 27, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- DermaRite Industries, LLC
- Distributor
- Nationwide in the USA
- Lot
- All lots on or before expiry date 08/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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