Lantiseptic 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 Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61…

Recall number

D-0170-2026

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

Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.