FDA recall D-0458-2025

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

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2025-05-23

Report date

2025-06-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Smyrna, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0458-2025