DermaFungal recalled over manufacturing violations

Recall date

August 27, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

DermaRite Industries, LLC recalls DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), a…

Recall number

D-0162-2026

FDA classification

Class II

Brand / firm

DermaRite Industries, LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.