FDA Drugs recall ·
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%… recall
- Recall number
- D-0458-2025
- Date
- (initiated May 23, 2025)
- Company / brand
- Consumer Product Partners, LLC
1 Swan Dr, Smyrna, TN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 125,040 bottles
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
Distribution
Nationwide in the USA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0458-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.