Hand Sanitizer Gel
FDA Recall NDC 53329-202
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Hand Sanitizer (NDC 53329-202). A significant event, classified as Class II, was initiated on May 23, 2025 by Medline Industries, Lp. The reported reason for this action was: "Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
May 23, 2025
Jun 11, 2025
125,040 bottles
Recall Profile & Regulatory Data
Event ID
96960
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Consumer Product Partners, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
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
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
Affected Packages Involved in this Recall
53329-202-13Product
53329-202-04Product
53329-202-08Product
53329-202-70Product
53329-202-84Product
53329-202-85Product
53329-202-74Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
