Medications & Supplements/Over-the-Counter

TheraTears Extra Eye Drops Recalled for Lack of Sterility Assurance

Agency Publication Date: March 24, 2022

Summary

Akorn, Inc. has voluntarily recalled 62,331 boxes of TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops because the product may not be sterile. The recall involves boxes containing 30 sterile single-use vials that were distributed nationwide. While no injuries have been reported, using non-sterile eye drops can lead to serious health complications.

Risk

A lack of sterility assurance means the eye drops could be contaminated with microorganisms. Applying non-sterile products to the eyes poses a risk of sight-threatening infections or other serious eye-related injuries.

What You Should Do

This recall affects TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops sold in boxes of 30 single-use vials under the Akorn Consumer Health brand.
Check your product packaging for NDC 58790-010-30 and lot numbers 913012, 913013, or 913014, all with an expiration date of 1/31/2023.
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: TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops (30-count box)

Variants: 0.25% strength, Single-Use Vials

Lot Numbers:

913012 (Exp. 1/31/2023)

913013 (Exp. 1/31/2023)

913014 (Exp. 1/31/2023)

NDC:

58790-010-30

Distributed by Akorn Consumer Health, Ann Arbor, MI.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89836

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: Retail pharmacies; Drug stores

Manufactured In: United States

Units Affected: 62,331 box

Distributed To: Nationwide

Agency Last Updated: March 29, 2022

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

This recall affects TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops sold in boxes of 30 single-use vials under the Akorn Consumer Health brand.

Check your product packaging for NDC 58790-010-30 and lot numbers 913012, 913013, or 913014, all with an expiration date of 1/31/2023.

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.