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AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Developm...

FDA Recall #D-0005-2026 — Class II — September 29, 2025

Recall #D-0005-2026 Date: September 29, 2025 Classification: Class II Status: Ongoing

Product Description

AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 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.

Recalling Firm

Acuity Specialty Products, Inc. — Chambersburg, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

US Nationwide.

Code Information

Lot # C2432725, Exp 11/22/2025; Lot # C2508304, Exp 3/24/2026; Lot # C2509304, Exp 4/3/2026.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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