FDA recall D-0699-2026

Product

Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,

Reason for recall

CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

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-0699-2026