AFCO 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 AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersbu…
- Recall number
- D-0005-2026
- 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
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.
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