Ketotifen Fumarate is an over-the-counter medicine. 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
- Over the counter (OTC)
- Brand names
- Eye Itch Relief
- Taken
- Ophthalmic
- Label
- CVS Pharmacy, revised August 31, 2026 · full label on DailyMed
Purpose
Antihistamine
What it is used for
For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
Active ingredient
Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)
Warnings
For external use only Do not use if you are sensitive to any ingredient in this product if solution changes color or becomes cloudy to treat contact lens related irritation When using this product remove contact lenses before use wait at least 10 minutes before re-inserting contact lenses after use do not touch tip of container to any surface to avoid contamination replace cap after each use Stop use and ask a doctor if you experience any of the following: eye pain changes in vision redness of the eyes itching that worsens or lasts for more than 72 hours
Keep out of reach of children
. If swallowed, get medical help or contact a Poison Control Center right away.
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.
Ketotifen in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Ongoing
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lots, distribution and details
- Product
- Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
- Lots / codes
- Lot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024
- Distribution
- Product was distrituded to three direct account in PA.
- Quantity
- 12 5mL bottles
- Recall started
- May 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0577-2023
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.
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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 7d0146a9-5073-4e24-954f-75b84affadc2.