HIGH

Acuity Specialty Products Hand Sanitizer Recalled for Methanol Risk Due to Unperformed Component-LOT

Acuity Specialty Products recalled hand sanitizer products sold nationwide due to potential methanol presence. The recall covers Wyandotte, Sanifect E3 ethanol-based sanitizer products manufactured by AFCO. The issue stems from unperformed receipt testing on incoming alcohol components. Consumers and healthcare providers should stop use immediately.

Quick Facts at a Glance

Recall Date
September 29, 2025
Hazard Level
HIGH
Brand
Acuity Specialty Products
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, INFANTS

Hazard Information

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.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Acuity Specialty Products, Inc. or your healthcare provider for guidance. Notification method: Letter

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About This Product

Wyandotte Sanifect E3 is an ethanol-based hand sanitizer used to disinfect hands. It comes in various packaging sizes for consumer and institutional use.

Why This Is Dangerous

The hazard arises from cGMP deviations leading to unverified methanol risk due to untested incoming alcohol components.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

Immediate stop-use is required. The recall affects a broad consumer base and healthcare settings that rely on hand sanitizers.

Practical Guidance

How to identify if yours is affected

  1. Check packaging for the Wyandotte Sanifect E3 hand sanitizer label.
  2. Verify Lot numbers: C2427010 (Exp 9/26/2025); C2432621 (Exp 11/21/2025); C2501514 (Exp 1/15/2026); C2508606 (Exp 3/27/2026).
  3. Discontinue use if lot matches above or if unsure.

Where to find product info

Lot numbers and expiration dates typically appear on the product label or cap.

What timeline to expect

Refund or replacement processing times are determined by recall coordination; healthcare facilities may receive guidance via notification letters.

If the manufacturer is unresponsive

  • Contact Acuity Specialty Products at 800-345-1329.
  • File a complaint with the FDA if necessary.

How to prevent similar issues

  • Purchase hand sanitizers from reputable brands with clear testing and lot traceability.
  • Ask vendors about cGMP compliance and lot testing before purchase.

Documentation advice

Keep the recall letter, product packaging, lot numbers, purchase receipts, and any correspondence with the company.

Product Details

Brand: Acuity Specialty Products. Product: Wyandotte Sanifect E3 Hand Sanitizer (Ethanol-Based, Product 5511). Active ingredient: Ethyl alcohol 60.1%. Manufacturer: AFCO, 550 Development Avenue, Chambersburg, PA 17210. Distribution: US nationwide. Packaging configurations: a) 6x1000 mL case, b) 4x1 gallon case, c) 5 gallon pail, d) 55 gallon drum. Recall number/dates: D-0004-2026; Recall date 2025-09-29; Report date 2025-10-15. Contact: Toll free 800-345-1329. Status: ACTIVE.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Recall number D-0004-2026
  • Product lines include 6x1000 mL, 4x1 gallon, 5 gallon pail, and 55 gallon drum packaging
  • Lot numbers include C2427010 with Exp 9/26/2025
  • Other lots: C2432621 Exp 11/21/2025; C2501514 Exp 1/15/2026; C2508606 Exp 3/27/2026
  • Hazard category: HIGH

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTINFANTSCHILDRENELDERLY
Injury Types
POISONING

Product Classification

Product Details

Model Numbers
Lot # C2427010
Exp 9/26/2025
Lot # C2432621
Exp 11/21/2025
Lot # C2501514
+3 more
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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