Why it was recalled
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Product description
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
Lot numbers, UPCs & expiration codes
Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0458-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 23, 2025
- FDA report date
- Jun 11, 2025
- Quantity
- 125,040 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Consumer Product Partners, LLC
Original FDA data
Every field from FDA enforcement report D-0458-2025, exactly as published.
Show all FDA fields
- City
- Smyrna
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 96960
- Address
- 1 Swan Dr
- Code information
- Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
- Postal code
- 37167-2099
- Report date
- Jun 11, 2025
- Product type
- Drugs
- Recall number
- D-0458-2025
- Classification
- Class II
- Recalling firm
- Consumer Product Partners, LLC
- Product quantity
- 125,040 bottles
- Reason for recall
- Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- May 23, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 5, 2025