HIGHFDA DRUG

AFCO Hand Sanitizer 5515 Recalled for Methanol Risk Nationwide (2025)

AFCO's hand sanitizer 5515 is being recalled nationwide through distributors and retailers. The recall cites cGMP deviations that left methanol risk unexcluded. Consumers and healthcare providers should stop using this product immediately and contact Acuity Specialty Products for guidance.

Official notice
AFCOHealth & Personal CareDrugs & MedicationsLot # C2432725Lot # C2508304Lot # C2509304

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
September 29, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
AFCO
Product type
Isopropyl Alcohol-Based Hand Sanitizer
Model numbers
Lot # C2432725, Lot # C2508304, Lot # C2509304
Sizes
4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    September 29, 2025

  2. Reported by FDA DRUG

    October 15, 2025

  3. RecallRadar source check

    April 18, 2026

  4. 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

AFCO hand sanitizer 5515 is sold for hand hygiene in workplaces and homes. It is an isopropyl alcohol-based formulation packaged in multiple configurations.

Why This Is Dangerous

The recall cites cGMP deviations that prevented methanol risk from being ruled out in the final product.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Consumers and healthcare providers must stop use immediately. The exposure risk could be significant, though no injuries have been reported.

Practical Guidance

How to identify if yours is affected

  1. Check lot numbers on the product packaging for C2432725, C2508304, or C2509304.
  2. Verify AFCO branding and 550 Development Avenue, Chambersburg, PA 17201 on the label.
  3. Note the package configurations: 4x1 Gallon Case, 5 Gallon Pail, or 55 Gallon Drum.

Where to find product info

Refer to the FDA recall page and Acuity Specialty Products guidance for next steps and potential refunds or replacements.

What timeline to expect

Refund or replacement processing may take several weeks; follow official instructions from Acuity Specialty Products.

If the manufacturer is unresponsive

  • Escalate by contacting the FDA recall helpline or your local health department.
  • Document communications with the supplier and retain recall materials.

How to prevent similar issues

  • Buy sanitizers from reputable brands with clear ingredient labeling.
  • Check batch codes and lot numbers before purchase.
  • Prefer products with USP or other recognized safety certifications.

Documentation advice

Keep the recall notice, photos of packaging, your purchase details, and all correspondence with the manufacturer.

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Product Details

Lot numbers affected: C2432725, C2508304, C2509304. Package configurations include 4x1 Gallon Case, 5 Gallon Pail, and 55 Gallon Drum. Sold nationwide across the US. Manufactured by AFCO, 550 Development Avenue, Chambersburg, PA 17201. Recall number D-0005-2026. Status: ACTIVE. Recall date: 2025-09-29. Report date: 2025-10-15.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Product 5515 Isopropyl Alcohol-Based Hand Sanitizer
  • Lot numbers C2432725, C2508304, C2509304
  • US nationwide distribution

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
GENERAL
Injury Types
POISONING

Product Classification

Product Details

Brand
Model Numbers
Lot # C2432725
Lot # C2508304
Lot # C2509304
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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