Medications & Supplements/Prescription Drugs

Akorn Betaxolol Ophthalmic Solution Recalled for Microbial Contamination

Agency Publication Date: October 7, 2021

Summary

Akorn, Inc. is recalling 10,210 bottles of Betaxolol Ophthalmic Solution (betaxolol hydrochloride), a sterile prescription eye drop. The recall was issued after stability testing at the 12-month mark confirmed a sterility failure, indicating potential microbial contamination. No injuries or adverse events have been reported to date. The product was distributed nationwide to pharmacies and healthcare providers.

Risk

Using a contaminated sterile eye product can cause serious eye infections, which may lead to vision loss or other permanent eye damage. Consumers with compromised immune systems or existing eye conditions are at the highest risk of severe complications.

What You Should Do

The recalled product is Betaxolol Ophthalmic Solution, USP, 0.5% (5 mL dropper bottle) sold under the Akorn brand with lot number 0B61A and an expiration date of 01/31/2022.
Check the product packaging for NDC codes 17478-705-10 (carton) or 17478-705-11 (bottle) to confirm if your medication is part of this recall.
If you have health concerns related to the use of this product, contact your healthcare provider or pharmacist immediately. 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) if you have additional questions or need to report a problem.

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: Betaxolol Ophthalmic Solution, USP, 0.5% (5 mL dropper bottle)

Variants: 5 mL dropper bottle, 0.5% (Betaxolol HCl 5.6 mg/mL), Rx Only

Lot Numbers:

0B61A (Exp 01/31/2022)

NDC:

17478-705-10

17478-705-11

Recall #: D-0004-2022; confirmed sterility failure at 12-month stability testing.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88823

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 10,210 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 Betaxolol Ophthalmic Solution, USP, 0.5% (5 mL dropper bottle) sold under the Akorn brand with lot number 0B61A and an expiration date of 01/31/2022.

Check the product packaging for NDC codes 17478-705-10 (carton) or 17478-705-11 (bottle) to confirm if your medication is part of this recall.

If you have health concerns related to the use of this product, contact your healthcare provider or pharmacist immediately. 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) if you have additional questions or need to report a problem.