Povidone-Iodine is a prescription medicine (Antiseptic). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Prescription only (Rx)
- Brand names
- Betadine
- Drug class
- Antiseptic
- Taken
- Ophthalmic
- Label
- Alcon Laboratories, Inc., revised June 29, 2022 · full label on DailyMed
- Generic
- No · details
What it is used for
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).
Who should not take it (contraindications)
Do not use on individuals known to be sensitive to iodine, or other components of this product.
Warnings
FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.
Precautions
General: No studies are available in patients with thyroid disorders; therefore, caution is advised in using BETADINE* 5% Sterile Ophthalmic Prep Solution in these patients due to the possibility of iodine absorption. Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term studies in animals have been performed to evaluate the carcinogenic or mutagenic potential of povidone-iodine. One report of the mutagenic potential of povidone-iodine indicated that it was positive in a modification of the Ames S. typhimurium model, but these results could not be reproduced by another researcher. Another test using mouse lymphoma and Balb/3T3 cells showed that povidone-iodine has no significant mutagenic or transformation capabilities. Other data indicated that it does not produce mutagenic effects in mice or hamsters according to the dominant lethal test, micronucleus test, and chromosome analysis. Pregnancy: Animal reproduction studies have not been conducted with BETADINE* 5% Sterile Ophthalmic Prep Solution. It is also not known whether BETADINE* 5% Sterile Ophthalmic Prep Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BETADINE* 5% Sterile Ophthalmic Prep Solution should only be used on a pregnant woman if clearly needed. Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from BETADINE* 5% Sterile Ophthalmic Prep Solution, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Side effects (adverse reactions)
Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.
Pregnancy
Animal reproduction studies have not been conducted with BETADINE* 5% Sterile Ophthalmic Prep Solution. It is also not known whether BETADINE* 5% Sterile Ophthalmic Prep Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BETADINE* 5% Sterile Ophthalmic Prep Solution should only be used on a pregnant woman if clearly needed.
Breastfeeding
Because of the potential for serious adverse reactions in nursing infants from BETADINE* 5% Sterile Ophthalmic Prep Solution, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Use in children
Safety and effectiveness in pediatric patients have not been established.
Use in older adults
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Is there a generic Povidone-Iodine?
No. The FDA has not approved a generic version yet.
Brand-name versions
- E-z Scrub 201 Becton Dickinson, approved 1985 Discontinued
- Betadine Alcon Pharms Ltd, approved 1986
- E-z Scrub 241 Becton Dickinson, approved 1987 Discontinued
- Povidone Iodine Allegiance Hlthcare, approved 1989
- E-z Prep Clinipad, approved 1989 Discontinued
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Povidone-iodine in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Ongoing
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.
Reason: sub potency
Lots, distribution and details
- Lots / codes
- Lots PO062402, Exp Date 6/30/2026, PO072401, Exp Date 7/30/2026, PO092401, Exp Date 9/30/2026, PO102401, Exp Date 10/31/2026 & PO102402, Exp Date 10/31/2026.
- Distribution
- Nationwide
- Quantity
- 8132 6-packs & 2262 2-packs
- Recall started
- June 4, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0627-2026
-
Class III Ongoing
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
Reason: Subpotent drug
Lots, distribution and details
- Lots / codes
- Lot # 24EJA180, Exp 06/01/2027
- Distribution
- Nationwide in the USA
- Quantity
- 2,680 bottles
- Recall started
- August 19, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0674-2025
-
Class II Ongoing
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-…
Reason: Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Lots, distribution and details
- Product
- First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80
- Lots / codes
- Lot, expiry: Lot 220901, Exp. 09/30/2024; Lot 230701, Exp. 07/31/2026; Lot 230301, Exp. 03/31/2026; Lot 230401, Exp. 04/30/2026; Lot 230501, Exp. 05/31/2026; Lot 230801, Exp. 08/31/2026; Lot 240301, Exp. 03/31/2027; Lot 240501, Exp. 04/30/2027.
- Distribution
- Distributed to one wholesaler in OH for Nationwide distribution.
- Quantity
- 295,164 tubes
- Recall started
- September 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0013-2025
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Povidone-Iodine
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID b026de1b-9949-4557-ac49-c7b0038c24cd.