May 2025 FDA Recall Hand Sanitizer by Consumer Product Partners, Llc
D-0458-2025 - Subpotent product
This Class II drug recall was voluntarily initiated by Consumer Product Partners, Llc on May 23, 2025 for the product Hand Sanitizer. The FDA reported the reason for recall as subpotent product. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0458-2025
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
05-23-2025
06-11-2025
125,040 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Consumer Product Partners, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
