FDA recall D-0692-2026

Blaine Labs Inc · Class I · drug

Product

Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.

Reason for recall

Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2026-04-08
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Fe Springs, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0692-2026