Povidone-iodine Solution
FDA Recall NDC 53329-939
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 Povidone-iodine (NDC 53329-939). A significant event, classified as Class III, was initiated on Aug 19, 2025 by Medline Industries, Lp. The reported reason for this action was: "Subpotent drug"
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 III Ongoing
Subpotent drug
Aug 19, 2025
Oct 01, 2025
2,680 bottles
Recall Profile & Regulatory Data
Event ID
97486
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Medline Industries, LP
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25
Batch or Lot Expiration Information
Lot# 24EJA180, Exp 06/01/2027
Affected Packages Involved in this Recall
53329-939-04Product
53329-939-06Product
53329-939-08Product
53329-939-23Product
53329-939-25Product
53329-939-69Product
53329-939-13Product
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.
