Is it safe to use LEADER Ultra Lubricating Eye Drops after this recall?

No. The recall cites a lack of assurance of sterility. Consumers should stop using affected bottles and contact KC Pharmaceuticals for guidance.

Which products are affected by this recall?

LEADER Ultra Lubricating Eye Drops and store-brand lubricating eye drops distributed nationwide are affected. Specific lots include SU24E01, SU24E02 and SU24K01 with Exp. dates of 5/31/26 or 9/30/26.

How can I identify if my bottle is affected?

Check the bottle for the product name, Lot numbers SU24E01, SU24E02 or SU24K01, and expiration dates of 5/31/26 or 9/30/26. Also check listed NDCs on packaging.

What should I do if I have an affected bottle?

Stop using the product immediately. Contact KC Pharmaceuticals or your healthcare provider for guidance. Follow the recall notification method by email.

Will I get a refund or replacement?

The recall summary notes guidance via recall notification by email. Specific refund or replacement details are not listed in the summary.

How do I report adverse events or concerns?

If you experience an adverse event, contact your healthcare provider and report to the appropriate federal agency if needed. Follow up with the recall notification for instructions.

What is the risk if I continue using the product?

Continued use could pose an infection or injury risk due to potential sterility failure. Discontinue use and consult a healthcare professional.

How widely is this recall distributed?

The recall covers products distributed nationwide in the United States and includes multiple retailers and store-brand labels.

What is the class of this recall?

The recall is Class II, indicating a temporary or reversible health risk.

Where can I find the recall posting?

The recall posting is available on the FDA enforcement site linked in the summary.

Will there be more information released?

Additional updates may be posted by the recall administrator and FDA. Check the linked enforcement page for the latest guidance.

HIGHMarch 3, 2026

LEADER Ultra Lubricating Eye Drops Recalled for Sterility Issue (2026)

Q: What brands are affected besides LEADER?

Store-brand lines such as Foster and Thrive, Goodsense, Meijer, Quality Choice, CVS Health, Walgreens, and Kroger brands are mentioned in the recall notes.

Cardinal Health distributed LEADER Ultra Lubricating Eye Drops and related store-brand lubricating eye drops nationwide. The recall cites a lack of assurance of sterility. Consumers should stop using these products immediately and contact KC Pharmaceuticals for guidance.

Quick Facts at a Glance

Recall Date: March 3, 2026
Hazard Level: HIGH
Brands: LEADER ULTRA LUBRICATING EYE DROPS, FOSTER AND THRIVE LUBRICATING TEARS LUBRICANT EYE DROPS, GOODSENSE ULTRA LUBRICANT EYE DROPS...
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

Lack of Assurance of Sterility

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact K.C. Pharmaceuticals, Inc or your healthcare provider for guidance. Notification method: E-Mail

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About This Product

Lubricant eye drops are OTC products used to relieve dry eye symptoms. They are distributed through multiple retailers and health care outlets.

Why This Is Dangerous

A lack of sterility can lead to eye infections or injury. Users should stop using affected products and seek professional guidance.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may experience eye irritation or infection. The recall covers a large nationwide quantity, creating a potential for widespread disruption and medical consultation needs.

Practical Guidance

How to identify if yours is affected

Check if your bottle is LEADER Ultra Lubricating Eye Drops or a listed store-brand variant
Look for Lot SU24E01, SU24E02, or SU24K01 and expiration dates 5/31/26 or 9/30/26
Verify associated NDCs listed on packaging (eg 70000-0457-1, 70677-1160-1, 50804-160-01, 41250-937-01, 83324-029-15, UPCs shown in recall)
If any identifier matches, discontinue use immediately
Document purchase details and recall communications for your records

Where to find product info

Packaging will show NDC, Lot number, and expiration date; UPCs may appear on store-brand packaging

What timeline to expect

4-8 weeks for refund or replacement processing

If the manufacturer is unresponsive

File a consumer complaint with the CPSC or FDA if the company delays
Maintain records of all correspondence and follow up regularly

How to prevent similar issues

Buy from reputable retailers and verify recall notices before use
Check packaging for sterile indicators and batch codes
When in doubt, contact your healthcare provider or pharmacist before using a product

Documentation advice

Keep the recall notice, product packaging, receipts, and all correspondence with the company

Product Details

Lot numbers include: Lot: a) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; b) SU24E01, Exp.: 5/31/26; c) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; d) SU24E01, SU24E02, Exp.: 5/31/26; e) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26. Distribution spans nationwide in the US by Cardinal Health and multiple store-brand labels including Foster and Thrive, Goodsense, Meijer, Quality Choice, CVS Health, Walgreens, Publix, Kroger, Harris Teeter, Perrigo Direct, and others. Total quantity recalled: 245,184 bottles. Some NDC references include 70000-0457-1 and others,

Reported Incidents

No injuries or incidents have been reported.

Key Facts

245,184 bottles recalled nationwide
Class II recall due to lack of sterility assurance
NDCs and lots include SU24E01, SU24E02, SU24K01 with Exp. 5/31/26 and 9/30/26
Background Section line breaks have been kept minimal to meet formatting needs.

View Original Recall on FDA - Drug Safety

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Safety Assessment

Risk LevelHIGH

Severity Score

6/ 10

Affected Groups

GENERAL

Injury Types

OTHERBURN

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypeLubricant Eye Drops

Product Details

Sep 2, 2025

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Presence of