Curad Alcohol Prep Pads Swab
FDA Recall NDC 53329-827
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 Curad Alcohol Prep Pads (NDC 53329-827). 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
1,639,996 pads
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
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30
Batch or Lot Expiration Information
Lot# 61224050002
Affected Packages Involved in this Recall
53329-827-60Product
53329-827-36Product
53329-827-30Product
53329-827-29Product
53329-827-40Product
53329-827-09Product
53329-827-33Product
6122405000Product
Class II Ongoing
Subpotent Drug
Feb 17, 2025
Mar 26, 2025
1,639,996 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
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.
Batch or Lot Expiration Information
Lot# SKU: CUR090737RB, Lot: 61224050002
Affected Packages Involved in this Recall
53329-827-60Product
53329-827-36Product
53329-827-30Product
53329-827-29Product
53329-827-40Product
53329-827-09Product
53329-827-33Product
6122405000Product
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.
