Class II · Moderate risk Ongoing
Renew PeriProtect
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Renew Skin Repair Cream
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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.
- Recalling firm
- DermaRite Industries, LLC
- NDC code
- 61924-405-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0175-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Dimethicone recalls
See all
Class II · Moderate risk Ongoing
4-N-1 Skin Protectant
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk Ongoing
Oatmeal Daily Moisturizing Body Lotion
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Class II · Moderate risk Terminated
LA FRESH travel lite Sunnyside Lotion Wipe silky
Reason Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.
Class II · Moderate risk Terminated
CeraVe Healing Lip Balm/SPF 30
Reason Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
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