North Bergen, NJ, United States
DermaRite Industries, LLC recalls
2 recalls recorded since 2018, most recently on 27 August 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)1
Ongoing Class II Drugs
- Recall started
- 27 August 2025
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0170-2026, D-0168-2026, D-0162-2026, D-0165-2026, D-0172-2026, D-0164-2026, D-0173-2026, D-0174-2026, D-0163-2026, D-0176-2026, D-0177-2026, D-0166-2026 and 6 more
- Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) t
- KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
- DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, No
- DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
- PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
- DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
- PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04
- and 10 more product lines
Ongoing Class I Drugs
- Recall started
- 17 July 2025
- Reason
- Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
- Distribution
- Nationwide within the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0613-2025, D-0611-2025, D-0610-2025, D-0612-2025
- PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
- DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
- DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Ind
- KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.