Wyandotte recalled over manufacturing violations

Recall date

September 29, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Acuity Specialty Products, Inc. recalls Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 De…

Recall number

D-0004-2026

FDA classification

Class II

Brand / firm

Acuity Specialty Products, Inc.

Sold / distributed

US Nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.