FDA Drug recall D-0611-2025
DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Berg…
- FDA Drug
- Class I
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class I recall of DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Berg… by Dermarite Industries, citing microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0611-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-07-17 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dermarite Industries |
| Distribution | US |
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
Reason
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Identifiers
| code_info | Lot #: 40187.2, Exp. Date 2/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2025-11-26 · Dermarite Industries - McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medi…
FDA Drug · Class II · 2025-11-26 · Dermarite Industries - PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North B…
FDA Drug · Class II · 2025-11-26 · Dermarite Industries - DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Berge…
FDA Drug · Class II · 2025-11-26 · Dermarite Industries - KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, N…
FDA Drug · Class II · 2025-11-26 · Dermarite Industries
All Dermarite Industries recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0611-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.