FDA Recall D-0170-2026

DermaRite Industries, LLC · North Bergen, NJ

Class II Ongoing 260 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

Lot / code: All lots on or before expiry date 08/2027

Quantity: 57,837 units

Reason for recall

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Recall record

Recall number: D-0170-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide in the USA
Recall initiated: 2025-08-27
Classified by FDA Center: 2025-11-20
FDA published: 2025-11-26
Recalling firm: DermaRite Industries, LLC
Firm location: North Bergen, NJ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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