August 2025 FDA Recall Povidone-iodine by Medline Industries, Lp
D-0674-2025 - Subpotent drug
This Class III drug recall was voluntarily initiated by Medline Industries, Lp on August 19, 2025 for the product Povidone-iodine. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0674-2025
Subpotent drug
08-19-2025
10-01-2025
2,680 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Medline Industries, LP
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.
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
