FDA Drug recall D-0458-2025
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lake…
- FDA Drug
- Class II
- ongoing
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class II recall of Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lake… by Consumer Product Partners, citing subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0458-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-23 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Consumer Product Partners |
| Distribution | US |
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
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Identifiers
| upc | 888277349455 |
|---|---|
| ndc | 53329-202-13 |
| ndc | 53329-202-04 |
| ndc | 53329-202-08 |
| ndc | 53329-202-70 |
| ndc | 53329-202-84 |
| ndc | 53329-202-85 |
| ndc | 53329-202-74 |
| code_info | Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0458-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.