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.
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.
Lot numbers, UPCs & expiration codes
Lot # C2432725, Exp 11/22/2025; Lot # C2508304, Exp 3/24/2026; Lot # C2509304, Exp 4/3/2026.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0005-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 29, 2025
- FDA report date
- Oct 15, 2025
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Acuity Specialty Products, Inc.
Original FDA data
Every field from FDA enforcement report D-0005-2026, exactly as published.
Show all FDA fields
- City
- Chambersburg
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97688
- Address
- 800 Development Ave
- Code information
- Lot # C2432725, Exp 11/22/2025; Lot # C2508304, Exp 3/24/2026; Lot # C2509304, Exp 4/3/2026.
- Postal code
- 17201-4103
- Report date
- Oct 15, 2025
- Product type
- Drugs
- Recall number
- D-0005-2026
- Classification
- Class II
- Recalling firm
- Acuity Specialty Products, Inc.
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Sep 29, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 6, 2025