The Recall Desk
HighFDA (Drugs)·D-0175-2026·Announced 2025-11-26

Renew Skin Repair Cream recalled due to manufacturing facility contamination concerns

DermaRite Industries recalled Renew Skin Repair Cream due to CGMP deviations at the manufacturing facility where other products were found contaminated. The recall affects 57,041 units distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves CGMP deviations at a manufacturing facility where documented contamination of other products occurred. With no reported illnesses or injuries from this product, this qualifies as a risk-of-harm scenario without reported injury, placing it in the High category per the rubric.

Plain-English summary

DermaRite Industries, LLC is recalling Renew Skin Repair Cream (Dimethicone 1.5%) in three package sizes: 5g tube (NDC 61924-405-05), 4 oz tube (NDC 61924-405-04), and 800 mL container (NDC 61924-405-27).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. Other products and lots produced at the same facility were found to be contaminated. A total of 57,041 units were distributed nationwide, with expiration dates on or before August 2027.

Consumers who have purchased this product should discontinue use. Contact DermaRite Industries or your healthcare provider if you have concerns or questions about your use of this cream.

The recalled product

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.
Manufacturer
DermaRite Industries, LLC
Category
Drug — Topical / Dermatological
Hazard
  • cgmp-deviation
  • manufacturing-contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots on or before expiry date 08/2027

Distribution

Distributed nationwide across the United States.

Related recalls

Same category