Recalls / Class II
Class IID-0600-2025
Product
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.
- Brand name
- Medline Alcohol Prep
- Generic name
- Isopropyl Alcohol
- Active ingredient
- Isopropyl Alcohol
- Route
- Topical
- NDC
- 53329-811
- FDA application
- M003
- Affected lot / code info
- 61224040057
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
- 6669874 swabs
- 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-0600-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.