HIGH

Medline Alcohol Prep Pads Recalled for Subpotent Isopropyl Alcohol in 6669874 Units

Medline Industries recalled 6,669,874 units of Alcohol Prep Pads nationwide after detecting subpotent isopropyl alcohol. The pads were distributed nationwide. The recall is classified as Class II with a high hazard level. Consumers and healthcare providers should stop using the product immediately and contact Medline for guidance.

Quick Facts at a Glance

Recall Date
July 7, 2025
Hazard Level
HIGH
Brand
Medline Alcohol Prep
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PETS

Hazard Information

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider for guidance. Notification method: Letter

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About This Product

Alcohol prep pads provide antiseptic preparation for skin before injections or procedures. They’re sold in clinical settings and homes.

Why This Is Dangerous

Subpotent isopropyl alcohol may reduce disinfection effectiveness, potentially increasing infection risk in medical settings.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

High urgency for clinicians and patients to replace with compliant pads to ensure proper antisepsis.

Practical Guidance

How to identify if yours is affected

  1. Check packaging for NDC 53329-811-30
  2. Look for model 61224040057
  3. Confirm pad count per box: 100 sterile 2-ply pads

Where to find product info

Recall notice and product identifiers are on FDA enforcement pages and Medline customer service materials.

What timeline to expect

Refunds or replacements typically processed in several weeks after submission of required documentation.

If the manufacturer is unresponsive

  • Escalate to Medline consumer affairs
  • File a complaint with CPSC if unresponsive

How to prevent similar issues

  • Verify lot numbers and NDCs before use
  • Prefer products with current FDA recall status
  • Maintain documentation of recall communications

Documentation advice

Keep packaging, lot numbers, purchase receipts, and all recall correspondence as records.

Product Details

Product: Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 sterile 2-ply pads per box. Sold nationwide. Manufacturer: Medline Industries, LP. NDC: 53329-811-30. Model: 61224040057. Quantity recalled: 6,669,874 swabs. Status: Active recall as of Sept 3, 2025. Recall date: 2025-07-07.

Reported Incidents

No injuries or incidents have been reported. The recall notice does not list injuries.

Key Facts

  • Subpotent isopropyl alcohol detected in 6,669,874 units
  • Recall class II with high hazard level
  • NDC 53329-811-30 and model 61224040057 listed
  • Distributed nationwide
  • No reported injuries to date
  • Remedy: stop use and contact Medline for guidance

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
GENERALPREGNANTPETS
Injury Types
POISONINGELECTRICAL

Product Details

Model Numbers
61224040057
UPC Codes
53329-811
53329-811-30
53329-811-09
+1 more
Affected States
ALL
Report Date
September 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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