Prescription and over-the-counter medicine
Povidone-iodine Brand names: Betadine; first approved as E-Z Scrub
Povidone-iodine (Betadine) is a prescription and over-the-counter medicine with an FDA approval on record since 1985. No generic is listed; pharmacies paid $0.0203 per mL (Povidone-iodine 10% solution) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the povidone-iodine FDA label on DailyMed (effective June 17, 2026); the NDA 19240 record on Drugs@FDA; every povidone-iodine label on DailyMed.
Highlights of the record
FDA label of June 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagefor antiseptic skin preparation
Forms and strengths
- 5 mg/ml
Solution.
On the market
- Earliest approval on file
- November 29, 1985 E-Z Scrub 201, Becton Dickinson; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included; 91 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.0203 per mL Povidone-iodine 10% solution
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2017 0 Class I among all firms' recalls; latest April 13, 2022; 9 more by firms not listed as its makers
- FAERS reports
- 4,203 through July 30, 2026
What is povidone-iodine used for?
From the label: indications and usagefor antiseptic skin preparation
FDA pharmacologic class: Antiseptic.
Source: FDA drug label (Povidone-Iodine Scrub Solution), Changzhou Maokang Medical Products Co., Ltd, effective June 17, 2026 (SPL set efa7f9f6-ae02-4104-bb9e-16e1ffd2be7a), via openFDA; the full label on DailyMed
Is there a generic for povidone-iodine (Betadine)?
No generic povidone-iodine is approved (Drugs@FDA, October 8, 2026).
- 1985 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for povidone-iodine (Betadine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0203 per mL (Povidone-iodine 10% solution), up 23% from $0.0165 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Povidone-iodine 10% solution (generic)
- Betadine 10% solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| First aid antiseptic 10% ointment | Generic | $0.0544 per gram | n/a | -9% |
| Ft povidone-iodine 10% solution | Generic | $0.0203 per mL | n/a | +7% |
| Gnp povidone-iodine 10% solution | Generic | $0.0143 per mL | n/a | +3% |
| Povidone-iodine 10% solution | Generic | $0.0203 per mL | n/a | +23% |
| Betadine 10% solution | Brand | $0.013 per mL | n/a | -0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has povidone-iodine been recalled?
The FDA's Enforcement Report lists 10 recalls naming povidone-iodine since 2017: 0 Class I (the most serious), 9 Class II, 1 Class III; 3 still ongoing. 9 of them are by firms that FDA's NDC Directory does not list as a maker of povidone-iodine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 4, 2026 | Class II | Elevate Oral Care not a listed maker | sub potency |
| August 19, 2025 | Class III | Medline Industries, LP not a listed maker | Subpotent drug |
| September 11, 2024 | Class II | Zhejiang Jingwei Pharmaceutical Co., Ltd. not a listed maker | Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". … |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| August 26, 2021 | Class II | AVRIO HEALTH L.P not a listed maker | Subpotent Drug |
| July 23, 2021 | Class II | Professional Disposables International, Inc not a listed maker | SubPotent: Out of Specification |
| February 15, 2018 | Class II | Medline Industries Inc not a listed maker | Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. |
| October 5, 2017 | Class II | Purdue Pharma, LP not a listed maker | Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for povidone-iodine?
The FDA Adverse Event Reporting System holds 4,203 reports that list povidone-iodine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 457 are coded as a death and 1,311 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Povidone-iodine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other