Recalls / Class II
Class IID-0458-2025
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
- Brand name
- Hand Sanitizer
- Generic name
- Ethyl Alcohol
- Active ingredient
- Alcohol
- Route
- Topical
- NDC
- 53329-202
- FDA application
- 505G(a)(3)
- Affected lot / code info
- Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
Why it was recalled
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Recalling firm
- Firm
- Consumer Product Partners, LLC
- Manufacturer
- Medline Industries, LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Swan Dr, N/A, Smyrna, Tennessee 37167-2099
Distribution
- Quantity
- 125,040 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2025-05-23
- FDA classified
- 2025-06-05
- Posted by FDA
- 2025-06-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0458-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.