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
- 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
- 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.
Recall announced
July 7, 2025
Reported by FDA DRUG
September 3, 2025
RecallRadar source check
April 18, 2026
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
- Check packaging for NDC 53329-811-30
- Look for model 61224040057
- 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.
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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
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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