CLASS II ONGOING Drug recall · Reported 11 Jun 2025 · FDA Enforcement Report
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol recalled
Consumer Product Partners is recalling Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70% per, distributed nationwide in the US. The recall was initiated on 23 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0458-2025
- FDA event ID
- 96960
- Recalling firm
- Consumer Product Partners, Smyrna, TN
- Brand
- Hand Sanitizer
- Manufacturer
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 May 2025
- FDA classified
- 5 Jun 2025
- Reported
- 11 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 23 May 2025 | Recall initiated by company | |
| 5 Jun 2025 | Classified by FDA | +13 days |
| 11 Jun 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Which lots are affected?
Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ethyl Alcohol recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Quik-care Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol) recalledQuik-care | Ecolab | Labeling Errors | Nationwide |
| Drug | CLASS II | Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), Ecolab recalledEcolab | Ecolab | Benzene | Nationwide |