Drug FDA Class III Ongoing Sub/super-potent

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

Medline Industries, LP Published Oct 1, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Medline Industries, LP or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Subpotent drug

Hazards

Subpotency · primary

Affected products (1)

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

POVIDONE-IODINE · 2,680 bottles

NDC: 53329-939, 53329-939-04, 53329-939-06, 53329-939-08, 53329-939-23, 53329-939-25, 53329-939-69, 53329-939-13

Lot codes: 24EJA180

Code info: Lot # 24EJA180, Exp 06/01/2027

Affected areas

Nationwide

Timeline

Initiated

Aug 19, 2025
Published

Oct 1, 2025

Recall number: D-0674-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.