Medications & Supplements/Prescription Drugs

Akorn Timolol Maleate Eye Drops Recalled for Unknown Impurity

Agency Publication Date: August 29, 2022

Summary

This recall involves Timolol Maleate Ophthalmic Solution (Akorn), a prescription medication used to treat glaucoma and eye pressure. Approximately 5,226 cartons (containing 60 single-dose vials each) are being recalled because an unknown impurity was discovered during stability testing at the 12-month mark. There have been no reports of injuries or adverse events related to this recall to date.

Risk

The presence of an unknown impurity means the medication failed to meet quality and purity specifications. Using eye drops with unidentified impurities could lead to reduced effectiveness of the treatment or unexpected side effects.

What You Should Do

The recalled product is Timolol Maleate Ophthalmic Solution, USP, 0.5%, sold in cartons of 60 single-dose vials under the Akorn, Inc. brand with NDC 17478-189-24.
To determine if your product is affected, check for lot number 9N72 with an expiration date of 09/30/2022 printed on the carton and individual vials.
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 more information 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: Timolol Maleate Ophthalmic Solution, USP, 0.5% (5 x 0.3 mL Single-Dose Vials)

Variants: 0.5%, Single-Dose Vials, Rx Only, Sterile

Lot Numbers:

9N72 (Exp 09/30/2022)

NDC:

17478-189-24

Recall #: D-1471-2022. Quantity: 5,226 Cartons (60 vials/carton).

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90720

Status: Active

Manufacturer: Akorn, Inc

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 5,226 Cartons (60 vials/carton)

Distributed To: Nationwide

Agency Last Updated: March 25, 2026

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

The recalled product is Timolol Maleate Ophthalmic Solution, USP, 0.5%, sold in cartons of 60 single-dose vials under the Akorn, Inc. brand with NDC 17478-189-24.

To determine if your product is affected, check for lot number 9N72 with an expiration date of 09/30/2022 printed on the carton and individual vials.

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 more information regarding this recall.