FDA recall D-0164-2026

Product

DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-08-27

Report date

2025-11-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Bergen, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0164-2026