Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), a
Summary
The FDA issued a Class II for Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405 by DermaRite Industries, LLC. Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated..
Details
Source
Drug Recall
External ID
D-0175-2026
Action Date
2025-11-26
Status
Ongoing
Category
drug
Product Description
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 Info: All lots on or before expiry date 08/2027
Quantity Affected: 57,041 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-27
Company
North Bergen, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 52 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
DermaRite Industries, LLC has 22 FDA actions in our database, including 22 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DermaRite Industries, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DermaRite Industries, LLC have FDA actions?
DermaRite Industries, LLC has 22 FDA actions in our database, including 22 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0175-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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