Medline Alcohol Prep Swab
FDA Recall NDC 53329-811
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Medline Alcohol Prep (NDC 53329-811). A significant event, classified as Class II, was initiated on Jul 07, 2025 by Medline Industries, Lp. The reported reason for this action was: "Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
July 2025 Class II Recall: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Recall Number
Class II Ongoing
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Jul 07, 2025
Sep 03, 2025
6669874 swabs
Recall Profile & Regulatory Data
Event ID
97385
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# 61224040057
Affected Packages Involved in this Recall
53329-811-30Product
53329-811-09Product
6122404005Product
Class II Ongoing
Subpotent Drug
Feb 17, 2025
Mar 26, 2025
6,669,874 pads
Recall Profile & Regulatory Data
Event ID
96404
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# SKU: MDS090670, Lot: 61224040057
Affected Packages Involved in this Recall
53329-811-30Product
53329-811-09Product
6122404005Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
