Medications & Supplements/Prescription Drugs

Akorn Olopatadine HCl Ophthalmic Solution Recalled for High Impurity Levels

Agency Publication Date: July 5, 2022

Summary

Akorn, Inc. is recalling 111,304 bottles of Olopatadine HCl Ophthalmic Solution (0.2%), a prescription eye drop used to treat allergy symptoms. The recall was initiated because retention samples showed levels of 2-HMP—a chemical that can leak from packaging into the medicine—that exceeded safety specifications. No injuries or adverse reactions have been reported in connection with this issue.

Risk

The eye drops contain high levels of an impurity called 2-HMP, which is a leachable substance from the packaging. Using a product that fails to meet purity specifications could lead to irritation or other unexpected side effects in the eyes.

What You Should Do

This recall affects 2.5 mL dropper bottles of Olopatadine HCl Ophthalmic Solution, USP, 0.2% (NDC 17478-305-12) manufactured by Akorn, Inc.
Check your medication packaging or bottle for lot numbers 1D90A or 1D92A with expiration dates of 3/2023, or lot number 1E30A with an expiration date of 4/2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Akorn, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Olopatadine HCl, Ophthalmic Solution, USP, 0.2% (2.5 mL)

Variants: 0.2%, 2.5 mL dropper bottle, Rx Only

Lot Numbers:

1D90A (Exp 3/2023)

1D92A (Exp 3/2023)

1E30A (Exp 4/2023)

NDC:

17478-305-12

Manufactured by Akorn, Inc. in Lake Forest, IL.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90344

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 111,304 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 2.5 mL dropper bottles of Olopatadine HCl Ophthalmic Solution, USP, 0.2% (NDC 17478-305-12) manufactured by Akorn, Inc.

Check your medication packaging or bottle for lot numbers 1D90A or 1D92A with expiration dates of 3/2023, or lot number 1E30A with an expiration date of 4/2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Akorn, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.