FDA Recall D-0611-2025

DermaRite Industries, LLC · North Bergen, NJ

Class I — life-threatening Ongoing 301 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

Lot / code: Lot #: 40187.2, Exp. Date 2/2026

Quantity: 249 bottles

Reason for recall

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

Recall record

Recall number: D-0611-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the USA
Recall initiated: 2025-07-17
Classified by FDA Center: 2025-09-02
FDA published: 2025-09-10
Recalling firm: DermaRite Industries, LLC
Firm location: North Bergen, NJ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

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

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