MEDLINE ALCOHOL PREP
Recalling Firm / Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
(Northfield, IL, United States)
FDA Recall Number: D-0600-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
MEDLINE ALCOHOL PREP
Generic Name
ISOPROPYL ALCOHOL
Active Substance(s)
Isopropyl Alcohol
Administration Route
Topical
National Drug Code (NDC)
53329-811
Total Quantity Recalled
6669874 swabs
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Full Product Description
Packaging specifications and labeling details
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
September 03, 2025
Firm Initiation Date
July 07, 2025
FDA Classification Date
Aug 26, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
61224040057
Distribution Information
Geographic scope of affected shipments
Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0600-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508613UTCC