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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Acuity Specialty Products
- Product type
- Alcohol-based Hand Sanitizer
- Model numbers
- Lot # C2427010, Exp 9/26/2025, Lot # C2432621, Exp 11/21/2025, Lot # C2501514, Exp 1/15/2026, Lot # C2508606, Exp 3/27/2026
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 29, 2025
Reported by FDA DRUG
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check packaging for the Wyandotte Sanifect E3 hand sanitizer label.
- 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.
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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
- Hazard category: HIGH
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Safety Guide
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