FDA Drug Recalls

Recalls / Class II

Class IID-0601-2025

Product

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

Brand name
Curad Alcohol Prep Pads
Generic name
Isopropyl Alcohol
Active ingredient
Isopropyl Alcohol
Route
Topical
NDC
53329-827
FDA application
M003
Affected lot / code info
61224050002

Why it was recalled

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

Recalling firm

Firm
MEDLINE INDUSTRIES, LP - Northfield
Manufacturer
Medline Industries, LP
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Quantity
1,639,996 pads
Distribution pattern
Nationwide

Timeline

Recall initiated
2025-07-07
FDA classified
2025-08-26
Posted by FDA
2025-09-03
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0601-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.