CLASS III ONGOING Drug recall · Reported 1 Oct 2025 · FDA Enforcement Report
Readyprep PVP, Povidone-Iodine 10% Solution recalled
Medline Industries is recalling Readyprep PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile per, distributed nationwide in the US. The recall was initiated on 19 Aug 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0674-2025
- FDA event ID
- 97486
- Recalling firm
- Medline Industries, Northfield, IL
- Brand
- Povidone-iodine
- Manufacturer
- Medline Industries, LP
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 19 Aug 2025
- FDA classified
- 24 Sep 2025
- Reported
- 1 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 19 Aug 2025 | Recall initiated by company | |
| 24 Sep 2025 | Classified by FDA | +36 days |
| 1 Oct 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Subpotent drug
Which lots are affected?
Lot # 24EJA180, Exp 06/01/2027
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medline Industries
All 707| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |
Other Povidone-iodine recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled | ImprimisRx NJ | Potency & Assay | Nationwide |
| Drug | CLASS II | BD PurPrep, (Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | Povi-One, 10% Povidone-Iodine Oral Antiseptic recalledPovi-one | Elevate Oral Care | Potency & Assay | Nationwide |
| Drug | CLASS II | BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |