FDAHealthAugust 27, 2025
DermaRite Industries, LLC — 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 Industrie
⚠️ CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 27, 2025
Nationwide in the USA
What's affected?
- Product
- 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.
- Lot code
- on
Additional details
All lots on or before expiry date 08/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 57,041 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.