Recalls / Class II

Class IID-0163-2026

Product

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.

Affected lot / code info

All lots on or before expiry date 08/2027

Why it was recalled

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Recalling firm

Firm

DermaRite Industries, LLC

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

7777 W Side Ave, North Bergen, New Jersey 07047-6436

Distribution

Quantity

7,736 tubes

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2025-08-27

FDA classified

2025-11-20

Posted by FDA

2025-11-26

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0163-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.