D-0162-2026Class II

DermaRite Industries, LLC

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-11-26

Distribution

Nationwide in the USA

Firm state

Product quantity

1,480 packets

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

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.

Code / lot info

All lots on or before expiry date 08/2027

Other recalls SPEQ maps to Environmental Monitoring

2026-07-22Class IFrutas y Hortalizas del Sur S.A.2026-07-22Class IIGELLERT GLOBAL GROUP 2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC

See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.