READYPREP PVP recall
FDA recall D-0674-2025 · initiated Aug 19, 2025
Medline Industries, LP recalled READYPREP PVP in Aug 2025 — an FDA Class III recall (D-0674-2025) because Subpotent drug.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Subpotent drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,680 bottles
Details
- 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
- Recalling company
- Medline Industries, LP
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Aug 19, 2025
- FDA report date
- Oct 1, 2025
Frequently asked
- Was READYPREP PVP recalled?
- Medline Industries, LP recalled READYPREP PVP in Aug 2025 — an FDA Class III recall (D-0674-2025) because Subpotent drug. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was READYPREP PVP recalled?
- Per the FDA enforcement record, the reason for recall D-0674-2025 was: Subpotent drug
- Is a recalled READYPREP PVP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of READYPREP PVP are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # 24EJA180, Exp 06/01/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0674-2025.