Ethanol hand sanitizer recalled because methanol risk could not be excluded
Acuity Specialty Products is recalling Wyandotte Sanifect E3 ethanol-based hand sanitizer because required receipt testing of incoming alcohol was not performed, so methanol risk could not be excluded.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: untested alcohol leaves methanol contamination unexcluded, a hazard for which no injury has been reported.
Plain-English summary
Wyandotte Sanifect E3 Hand Sanitizer (ethanol-based, Product 5511), ethyl alcohol 60.1%, manufactured by AFCO of Chambersburg, Pennsylvania, is being recalled for cGMP deviations. The product was supplied in 6x1000mL cases and 4x1 gallon cases among other configurations.
The recall was initiated because required receipt testing of the incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
The recall covers lots including C2427010 (expiring 26 September 2025), C2432621 (expiring 21 November 2025), C2501514 (expiring 15 January 2026) and C2508606, distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record describes an unverified raw material rather than confirmed methanol, and reports no injuries. Anyone holding the listed lots should stop using them and follow the firm's instructions.
The recalled product
- 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…
- Manufacturer
- Acuity Specialty Products, Inc.
- Category
- Drug — Hand sanitizer
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot # C2427010
- Exp 9/26/2025
- Lot # C2432621
- Exp 11/21/2025
- Lot # C2501514
- Exp 1/15/2026
- Lot # C2508606
- Exp 3/27/2026.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Acuity Specialty Products, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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