HIGHFDA DRUG

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

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.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
March 3, 2026
Status
ACTIVE
Severity
6/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
LEADER ULTRA LUBRICATING EYE DROPS, FOSTER AND THRIVE LUBRICATING TEARS LUBRICANT EYE DROPS, GOODSENSE ULTRA LUBRICANT EYE DROPS, MEIJER ULTRA LUBRICANT EYE DROPS HIGH PERFORMANCE +4 more
Product type
Lubricant Eye Drops
Model numbers
Lot: a) SU24E01, SU24E02, Exp.: 5/31/26, SU24K01, Exp.: 9/30/26, b) SU24E01, Exp.: 5/31/26, c) SU24E01 +12 more
UPC codes
70000-0457, 70677-1160, 50804-160, 41250-937, 83324-029, 70000-0457-1, 70000-0457-2, 70677-1160-1 +4 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 3, 2026

  2. Reported by FDA DRUG

    April 8, 2026

  3. RecallRadar source check

    April 15, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

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

  1. Check if your bottle is LEADER Ultra Lubricating Eye Drops or a listed store-brand variant
  2. Look for Lot SU24E01, SU24E02, or SU24K01 and expiration dates 5/31/26 or 9/30/26
  3. 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)
  4. If any identifier matches, discontinue use immediately
  5. 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

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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.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
6/ 10
Affected Groups
GENERAL
Injury Types
OTHERBURN

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