PlainRecordsFDA · Drug recall
Wyandotte… and 1 more product
- Date
- Oct. 15, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- Acuity Specialty Products, Inc.
- Reason
- 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.
2 products in this recall
Wyandotte…
- Product
- 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.
- Codes and lots
- Lot # C2427010, Exp 9/26/2025; Lot # C2432621, Exp 11/21/2025; Lot # C2501514, Exp 1/15/2026; Lot # C2508606, Exp 3/27/2026.
- Recall started
- Sept. 29, 2025
- Recall number
- D-0004-2026
AFCO…
- 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.
- Codes and lots
- Lot # C2432725, Exp 11/22/2025; Lot # C2508304, Exp 3/24/2026; Lot # C2509304, Exp 4/3/2026.
- Recall started
- Sept. 29, 2025
- Recall number
- D-0005-2026
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-0004-2026, D-0005-2026. The agency record governs; check it and the company before acting.