HIGHFDA DRUG

Leader Artificial Tears Recalled 589,848 Bottles for Sterility Issue in 2026

Leader Artificial Tears Sterile Lubricant Eye Drops sold nationwide are recalled due to lack of assurance of sterility. The recall involves multiple store-brand lines distributed by Cardinal Health and others. Consumers should stop using the product immediately and follow recall guidance from KC Pharmaceuticals via email.

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
8/10

Quick Facts at a Glance

Recall Date
March 3, 2026
Hazard Level
HIGH
Brands
Leader, Good Sense, Good Neighbor Pharmacy...
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, Good Sense, Good Neighbor Pharmacy, Quality Choice +7 more
Product type
Artificial Tears Eye Drops
Model numbers
AT24D01, AT24E01, AT24E02, AT24G01
UPC codes
70000-0011, 50804-110, 24385-006, 83324-189, 70000-0011-1, 50804-110-01, 24385-006-05, 83324-189-14
Sizes
0.5 FL OZ (15 mL)
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

Artificial Tears Sterile Lubricant Eye Drops are OTC products used to relieve dryness and irritation in the eyes. They are sold under multiple store-brand lines and distributed nationwide.

Why This Is Dangerous

Lack of sterility can expose users to eye infections or other complications. The issue concerns several lot codes across multiple brand lines.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Consumers may face eye infection risk. The recall affects nearly 590k bottles, potentially impacting patients and healthcare providers who distribute these products.

Practical Guidance

How to identify if yours is affected

  1. Review bottle label for product name and size.
  2. Check for lot numbers AT24D01, AT24E01, AT24E02, AT24G01 and expiration dates 04/30/26, 05/31/26, 07/31/26.
  3. Identify distributor lines such as Leader, Good Sense, Good Neighbor Pharmacy, Quality Choice, etc.

Where to find product info

Lot codes and expiration dates appear on the bottle label and carton. Official recall details are on the FDA enforcement page linked above.

What timeline to expect

Refund or replacement processing typically occurs within 4-6 weeks after confirmation of eligibility.

If the manufacturer is unresponsive

  • Escalate the request by replying to the recall notice email or contacting the FDA recall helpline.
  • Keep all correspondence and confirmation numbers for records.

How to prevent similar issues

  • When buying eye drops, check for current recall status and verify lot numbers and expiration dates.
  • Buy from reputable retailers and consider alternatives from established brands not listed in the recall.
  • Always inspect packaging for tampering before use.

Documentation advice

Keep product packaging, purchase receipts, and all recall communications. Document lot numbers and expiration dates for records.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

Product: Artificial Tears Sterile Lubricant Eye Drops Size: 0.5 FL OZ (15 mL) bottles NDCs: 70000-0011-1; 50804-110-01; 24385-006-05 UPCs: 0 36800 09331 7; 0 70038 47008 3; 0 11110 38600 7; 0 41415 00976 9 Lot numbers: AT24D01; AT24E01; AT24E02; AT24G01 Expirations: 04/30/26; 05/31/26; 07/31/26 Distributors/Brands: Leader (Cardinal Health, Perrigo Direct, AmerisourceBergen, TopCare, Best Choice, Kroger, Publix, Quality Choice) Quantity recalled: 589,848 bottles Recall date: 2026-03-03 Recall number: D-0416-2026 Status: Active Hazard: Lack of Assurance of Sterility Remedy: Stop using the eye-dh

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Multiple brands and distributors affected
  • Lot numbers AT24D01, AT24E01, AT24E02, AT24G01

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeArtificial Tears Eye Drops
Sold At
Multiple Retailers

Product Details

Model Numbers
AT24D01
AT24E01
AT24E02
AT24G01
UPC Codes
70000-0011
50804-110
24385-006
+5 more
Affected States
ALL
Report Date
April 8, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

Related Recalls