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Drug FDA Class II Ongoing Sub/super-potent

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

MEDLINE INDUSTRIES, LP - Northfield Published Sep 3, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact MEDLINE INDUSTRIES, LP - Northfield or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

Hazards

Subpotency - Isopropyl Alcohol Below Labeled Concentration · primary

Affected products (1)

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

CURAD ALCOHOL PREP PADS · 1,639,996 pads

NDC: 53329-827, 53329-827-60, 53329-827-36, 53329-827-30, 53329-827-29, 53329-827-40, 53329-827-09, 53329-827-33, 6122405000
Code info: 61224050002

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 7, 2025
  2. Published
    Sep 3, 2025
Recall number
D-0601-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.