Quick answers
- What is Povidone-iodine used for?
- The FDA-approved label (Betadine, Alcon Laboratories, Inc., June 29, 2022) says: “BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Povidone-iodine have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Povidone-iodine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Povidone-iodine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Povidone-iodine?
- 1 company lists prescription products of Povidone-iodine in the FDA NDC Directory, including Alcon Laboratories, Inc..
What Povidone-iodine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).
— FDA label: Betadine, Alcon Laboratories, Inc., effective June 29, 2022. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Ophthalmic |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Betadine |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Alcon Laboratories, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018634 BETADINE | Alcon Pharms Ltd | December 17, 1986 | 6, latest August 26, 2013 2013: Manufacturing (CMC) · 2003: Labeling · 2000: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1008-2022
cGMP deviations: Temperature abuse
Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd for: Alcon Surgical Inc., NDC 0065-0411-30 — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 312570, 1149663 |
|---|---|
| SPL set ID of the quoted label | b026de1b-9949-4557-ac49-c7b0038c24cd |
| FDA labels (SPL) | 1 |
| FDA applications | NDA018634 |
| Active ingredients (FDA) | POVIDONE-IODINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Betadine, Alcon Laboratories, Inc., effective June 29, 2022; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →