Olopatadine Hydrochloride 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 Allergy Itch Relief, Allergy Relief Eye Drops, Eye Allergy Itch Relief Once Daily Relief, Eye Allergy Itch and Redness Relief, Pataday Once Daily Relief
- Taken
- Ophthalmic
- Label
- Alcon Laboratories, Inc., revised January 20, 2026 · full label on DailyMed
Purpose
Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine
What it is used for
temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
Active ingredient
Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine
Do not use
if solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation
When using this product do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use do not wear a contact lens if your eye is red
Stop use and ask a doctor if
you experience: eye pain changes in vision increased redness of the eye itching worsens or lasts for more than 72 hours
Warnings
For external use only
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.
Olopatadine in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Ongoing
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05
Reason: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Lots, distribution and details
- Lots / codes
- Lot #: 35000409, Exp. Date 01/2026
- Distribution
- Nationwide within the United States
- Quantity
- 8,952 bottles
- Recall started
- October 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0034-2026
-
Class II Ongoing
Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0860-2023
-
Class II Ongoing
Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0833-2023
-
Class II Ongoing
Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0832-2023
-
Class II Ongoing
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
- Lots / codes
- Lot: 1C61A, EXP 2/28/2023; 1D86A, 1D07A, EXP 3/31/2023;
- Distribution
- Nationwide in the USA
- Quantity
- 121,176 bottles
- Recall started
- October 13, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0151-2023
-
Class II Ongoing
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012.…
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
- Lots / codes
- Lot: 1L16A, 1L17A, EXP 10/31/2023; 1M29A, EXP 11/30/2023; 2A05A, EXP 12/31/2023;
- Distribution
- Nationwide in the USA
- Quantity
- 163,996 bottles
- Recall started
- October 13, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0150-2023
-
Class II Ongoing
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
- Lots / codes
- Lot: 0L48A, EXP 10/31/2022; 0L55A, EXP 10/31/2022; 1C75A, EXP 2/28/2023; 1E18A, 1E20A , EXP 4/30/2023;
- Distribution
- Nationwide in the USA
- Quantity
- 173,928 bottles
- Recall started
- October 13, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0149-2023
-
Class II Ongoing
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
- Lots / codes
- Lot: 1L03A, EXP 10/31/2023
- Distribution
- Nationwide in the USA
- Quantity
- 1,752 bottles
- Recall started
- October 13, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0148-2023
-
Class II Ongoing
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05
Reason: CGMP Deviations:
Lots, distribution and details
- Product
- Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05
- Lots / codes
- Lot: Lot 1B41A, EXP 1/31/2023
- Distribution
- Nationwide in the USA
- Quantity
- 31,073 bottles
- Recall started
- October 13, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0147-2023
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 1c7d2342-ba1c-4244-9814-d92a05725d4e.