FDA Recall D-0458-2025

Consumer Product Partners, LLC · Smyrna, TN

Class II Ongoing 356 days on record

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

Product

Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5

Lot / code: Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16

Quantity: 125,040 bottles

Reason for recall

Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol

Recall record

Recall number: D-0458-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA.
Recall initiated: 2025-05-23
Classified by FDA Center: 2025-06-05
FDA published: 2025-06-11
Recalling firm: Consumer Product Partners, LLC
Firm location: Smyrna, TN

Drug identification

Brand name(s): HAND SANITIZER
Generic name(s): ETHYL ALCOHOL
Manufacturer(s): Medline Industries, LP
NDC(s): 53329-202
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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