Spectrum Advanced Gel Hand Sanitizer recall
FDA recall D-0458-2025 · initiated May 23, 2025
Consumer Product Partners, LLC recalled Spectrum Advanced Gel Hand Sanitizer in May 2025 — an FDA Class II recall (D-0458-2025) because Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 125,040 bottles
Details
- 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
- Recalling company
- Consumer Product Partners, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- May 23, 2025
- FDA report date
- Jun 11, 2025
Frequently asked
- Was Spectrum Advanced Gel Hand Sanitizer recalled?
- Consumer Product Partners, LLC recalled Spectrum Advanced Gel Hand Sanitizer in May 2025 — an FDA Class II recall (D-0458-2025) because Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Spectrum Advanced Gel Hand Sanitizer recalled?
- Per the FDA enforcement record, the reason for recall D-0458-2025 was: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
- Is a recalled Spectrum Advanced Gel Hand Sanitizer dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Spectrum Advanced Gel Hand Sanitizer are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0458-2025.