Why it was recalled
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Product description
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
Lot numbers, UPCs & expiration codes
All lots on or before expiry date 08/2027.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0160-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 27, 2025
- FDA report date
- Nov 26, 2025
- Quantity
- 3,178 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- DermaRite Industries, LLC
Original FDA data
Every field from FDA enforcement report D-0160-2026, exactly as published.
Show all FDA fields
- City
- North Bergen
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97625
- Address
- 7777 W Side Ave
- Code information
- All lots on or before expiry date 08/2027.
- Postal code
- 07047-6436
- Report date
- Nov 26, 2025
- Product type
- Drugs
- Recall number
- D-0160-2026
- Classification
- Class II
- Recalling firm
- DermaRite Industries, LLC
- Product quantity
- 3,178 bottles
- Reason for recall
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 27, 2025
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 20, 2025