DermaRite Industries, LLC: Drug Recall

Recall #D-0162-2026 · 08/27/2025

Class II: Risk

Recall Details

Recall Number
D-0162-2026
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
1,480 packets

Reason for Recall

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

Product Description

DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

Distribution Pattern

Nationwide in the USA

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.