CLASS II ONGOING Drug recall · Reported 26 Nov 2025 · FDA Enforcement Report
4-N-1 Skin Protectant, No Rinse Wash Cream recalled
DermaRite Industries is recalling 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1% per, DermaRite Industries, distributed nationwide in the US. The recall was initiated on 27 Aug 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0160-2026
- FDA event ID
- 97625
- Recalling firm
- DermaRite Industries, North Bergen, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Aug 2025
- FDA classified
- 20 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 27 Aug 2025 | Recall initiated by company | |
| 20 Nov 2025 | Classified by FDA | +85 days |
| 26 Nov 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Which lots are affected?
All lots on or before expiry date 08/2027.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
17 other products · FDA event 97625This product is part of a recall event; the main page for the event is Lantiseptic, Skin Protectant, Lanolin recalled by DermaRite Industries.
More recalls from DermaRite Industries
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%) recalled | DermaRite Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | McKesson Skin Protectant, Lanolin recalled by DermaRite IndustriesSkin Protectant With Lanolin | DermaRite Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lantiseptic, Dry Skin Therapy, Lanolin recalled by DermaRite Industries | DermaRite Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Renew Skin Repair Cream, Dimethicone recalled by DermaRite Industries | DermaRite Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hand-E-Foam, Benzethonium Chloride recalled by DermaRite Industries | DermaRite Industries | Manufacturing (CGMP) Deviations | Nationwide |