4-N-1 Skin Protectant — Class II drug recall D-0160-2026
Ongoing recall by DermaRite Industries, LLC, reported 2025-11-26, distributed nationwide. CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
| Recall number | D-0160-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DermaRite Industries, LLC, North Bergen, NJ, United States |
| Recall initiated | 2025-08-27 |
| Classified | 2025-11-20 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 3,178 bottles |
| Reason classes | cgmp |
| NDC | 61924-0208-04 |
| Expiration dates | 2027-08 |
Product
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
Reason for recall
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0160-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.