HIGHFDA DRUG

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.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
July 7, 2025
Status
ACTIVE
Severity
8/10

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

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
Medline Alcohol Prep
Product type
Alcohol Prep Pads
Model numbers
61224040057
UPC codes
53329-811, 53329-811-30, 53329-811-09, 6122404005
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    July 7, 2025

  2. Reported by FDA DRUG

    September 3, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

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.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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
  • 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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

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

Related Recalls

Health & Personal Care
MEDIUM

AvKARE Recalls Rosuvastatin Tablets Due to Dissolution Issues

AvKARE recalled 7,991 cartons of Rosuvastatin Tablets on December 31, 2025. The recall stems from the product being out of specification for dissolution. Consumers should stop using the medication immediately and consult healthcare providers for guidance.

SUN PHARMACEUTICAL INDUSTRIES
Labeling: Not
Read more