FDA recall D-0004-2026

Acuity Specialty Products, Inc. · Class II · drug

Product

Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.

Reason for recall

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2025-09-29
Report date
2025-10-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chambersburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0004-2026