Drug & medication recalls Moderate risk

Renew Skin Repair Cream 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 Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04),…
Recall number
D-0175-2026
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

Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

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