Drug FDA Class II Ongoing Sub/super-potent
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
Consumer Product Partners, LLC Published Jun 11, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Consumer Product Partners, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Hazards
Subpotency - Ethyl Alcohol Content Below 70% · primary
Affected products (1)
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
HAND SANITIZER · 125,040 bottles
NDC: 53329-202, 53329-202-13, 53329-202-04, 53329-202-08, 53329-202-70, 53329-202-84, 53329-202-85, 53329-202-74
Lot codes: 0644682, 0644683
Code info: Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
Affected areas
Nationwide
Timeline
- InitiatedMay 23, 2025
- PublishedJun 11, 2025
- Recall number
- D-0458-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.