FDA recall D-0166-2026

DermaRite Industries, LLC · Class II · drug

Product

GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2025-08-27
Report date
2025-11-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Bergen, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0166-2026