Povidone-iodine recalls

The FDA has published 15 recalls involving Povidone-iodine since 2012. The latest was reported on 16 Sep 2026. Most were for sterility. CareFusion 213 has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls15since 2012

Last 12 months5reported

Class I00% of total

Ongoing7latest 16 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 1 0Nov 0 0 0Feb 0 0 2May 0 2 0Aug 1 0

Severity split

Class I 0 0%Class II 13 87%Class III 2 13%

Why povidone-iodine is recalled

Companies

Brands

By year

2026533%
202517%
202417%
202217%
202117%
201917%
201817%
2017213%
2012213%

Ongoing povidone-iodine recalls

7 active

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS III	Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled	ImprimisRx NJ	Potency & Assay	Nationwide
8 Jul 2026Drug	CLASS II	BD PurPrep, (Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep	CareFusion 213	Sterility	Nationwide
1 Jul 2026Drug	CLASS II	Povi-One, 10% Povidone-Iodine Oral Antiseptic recalledPovi-one	Elevate Oral Care	Potency & Assay	Nationwide
13 May 2026Drug	CLASS II	BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep	CareFusion 213	Sterility	Nationwide
13 May 2026Drug	CLASS II	BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep	CareFusion 213	Sterility	Nationwide
1 Oct 2025Drug	CLASS III	Readyprep PVP, Povidone-Iodine 10% Solution recalledPovidone-iodine	Medline Industries	Potency & Assay	Nationwide

All povidone-iodine recalls, newest first

15 total

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS III	Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled	ImprimisRx NJ	Potency & Assay	Nationwide
8 Jul 2026Drug	CLASS II	BD PurPrep, (Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep	CareFusion 213	Sterility	Nationwide
1 Jul 2026Drug	CLASS II	Povi-One, 10% Povidone-Iodine Oral Antiseptic recalledPovi-one	Elevate Oral Care	Potency & Assay	Nationwide
13 May 2026Drug	CLASS II	BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep	CareFusion 213	Sterility	Nationwide
13 May 2026Drug	CLASS II	BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep	CareFusion 213	Sterility	Nationwide
1 Oct 2025Drug	CLASS III	Readyprep PVP, Povidone-Iodine 10% Solution recalledPovidone-iodine	Medline Industries	Potency & Assay	Nationwide
23 Oct 2024Drug	CLASS II	First Aid Antiseptic Ointment, Povidone Iodine recalledFirst Aid Antiseptic	Zhejiang Jingwei Pharmaceutical	Labeling Errors	Nationwide
15 Jun 2022Drug	CLASS II	Betadine 5%, Sterile Ophthalmic Prep Solution recalledBetadine	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
29 Sep 2021Drug	CLASS II	Betadine Solution Swabstick Povidone-Iodine Solution recalledBetadine	Avrio Health	Potency & Assay	Nationwide
30 Oct 2019Drug	CLASS II	Povidone Iodine, 5% Ophthalmic Solution per droptainer recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
7 Mar 2018Drug	CLASS II	PVP Scrub Solution, Povidone Iodine recalled by Medline IndustriesPovidone-iodine	Medline Industries	Potency & Assay	Nationwide
15 Nov 2017Drug	CLASS II	Betadine Solution Swabstick Povidone-Iodine Solution recalledBetadine	Purdue Pharma	Potency & Assay	Nationwide
13 Sep 2017Drug	CLASS II	Povidone Iodine, USP Prep Solution recalled by Degasa Sa De Cv	Degasa	Packaging Defects	CA, IL
22 Aug 2012Drug	CLASS II	Povidone-iodine/lidocaine/tetracaine 4.6%/4%/0.5% recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide
22 Aug 2012Drug	CLASS II	Povidone-iodine Ophthalmic 5% Solution recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Povidone-iodine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.