4-N-1 Skin Protectant recall — Class II (D-0160-2026) · pharmaranks
Class IIOngoing
4-N-1 Skin Protectant recall
FDA recall D-0160-2026 · initiated Aug 27, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Details
Product
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
Recalling company
DermaRite Industries, LLC
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the USA
Initiated
Aug 27, 2025
FDA report date
Nov 26, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.