D-0004-2026 Class II Ongoing
FDA drug recall D-0004-2026 was initiated by Acuity Specialty Products, Inc. on September 29, 2025 and is designated Class II. 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 b… The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- October 15, 2025
- Initiation Date
- September 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
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.
Distribution Pattern
US Nationwide.
Code Information
Lot # C2427010, Exp 9/26/2025; Lot # C2432621, Exp 11/21/2025; Lot # C2501514, Exp 1/15/2026; Lot # C2508606, Exp 3/27/2026.