FDA Recall D-0600-2025

MEDLINE INDUSTRIES, LP - Northfield · Northfield, IL

Class II Ongoing 311 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: 61224040057

Quantity: 6669874 swabs

Reason for recall

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

Recall record

Recall number: D-0600-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2025-07-07
Classified by FDA Center: 2025-08-26
FDA published: 2025-09-03
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Firm location: Northfield, IL

Drug identification

Brand name(s): MEDLINE ALCOHOL PREP
Generic name(s): ISOPROPYL ALCOHOL
Manufacturer(s): Medline Industries, LP
NDC(s): 53329-811
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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