Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%,… recall
FDA recall D-0004-2026 · initiated Sep 29, 2025
Acuity Specialty Products, Inc. recalled Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alco… in Sep 2025 — an FDA Class II recall (D-0004-2026) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
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.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- 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.
- Recalling company
- Acuity Specialty Products, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Sep 29, 2025
- FDA report date
- Oct 15, 2025
Frequently asked
- Was Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alco… recalled?
- Acuity Specialty Products, Inc. recalled Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alco… in Sep 2025 — an FDA Class II recall (D-0004-2026) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alco… recalled?
- Per the FDA enforcement record, the reason for recall D-0004-2026 was: 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.
- Is a recalled Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alco… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alco… are affected?
- Distributed: US Nationwide.. The recall covers these 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0004-2026.