Recalls / Class II
Class IID-0005-2026
Product
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.
- Affected lot / code info
- Lot # C2432725, Exp 11/22/2025; Lot # C2508304, Exp 3/24/2026; Lot # C2509304, Exp 4/3/2026.
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.
Recalling firm
- Firm
- Acuity Specialty Products, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 800 Development Ave, Chambersburg, Pennsylvania 17201-4103
Distribution
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-09-29
- FDA classified
- 2025-10-06
- Posted by FDA
- 2025-10-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0005-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.