HIGH

KC Pharmaceuticals Sterile Eye Drops Soothing Tears Recall 74,016 Bottles (2026)

KC Pharmaceuticals recalls 74,016 bottles of Sterile Eye Drops Soothing Tears distributed nationwide by Rugby Laboratories and Walgreens. The recall cites a lack of assurance of sterility. Consumers and healthcare providers should stop using the product immediately and contact KC Pharmaceuticals for guidance.

Quick Facts at a Glance

Recall Date
March 3, 2026
Hazard Level
HIGH
Brand
KC Pharmaceuticals
Category
Health & Personal Care
Sold At
Walgreens, 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

Eye drops used to relieve dryness and irritation. Sterile formulations require strict manufacturing controls to prevent contamination.

Why This Is Dangerous

A lack of sterility can lead to eye infections or other ocular problems. Users should discontinue use if they have concerns.

Industry Context

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

Real-World Impact

Without sterility, users risk infections and potential vision complications. Consumers should stop use and seek guidance promptly.

Practical Guidance

How to identify if yours is affected

  1. Check your bottle for NDC 0536-1219-94 and UPC 3-11917-20300-3
  2. Look for Lot SY24K01 or SY24K02 on the bottle
  3. Verify expiry date 09/30/2026
  4. Confirm distributor as Rugby Laboratories or Walgreens

Where to find product info

Identifiers appear on the bottle label and packaging: NDC, UPC, Lot, Expiry. The recall notice provides the official guidance.

What timeline to expect

Refund or replacement processing commonly takes 4-6 weeks after verification.

If the manufacturer is unresponsive

  • Document all communications with KC Pharmaceuticals.
  • File a consumer safety complaint with the FDA if the company is unresponsive.
  • Consider seeking guidance from a healthcare professional and preserving the product for evidence.

How to prevent similar issues

  • Check labels before purchase for NDC and Lot number.
  • Avoid purchasing from unverified sources.
  • Always inspect expiry dates before use.
  • Register recalls with consumer safety databases when available.

Documentation advice

Keep the product, packaging, purchase receipts, recall notice, and all correspondence with the company for records.

Product Details

Size: 0.5 oz (15 mL) bottles. NDC 0536-1219-94. UPC 3-11917-20300-3. Lot SY24K01 and Lot SY24K02. Exp. 09/30/2026. Sold nationwide in the United States. Distributors: Rugby Laboratories, Livonia, MI 48152; Walgreens Co., Deerfield, IL 60015. Quantity: 74,016 bottles.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 74,016 bottles recalled
  • Lack of Assurance of Sterility cited
  • NDC 0536-1219-94; UPC 3-11917-20300-3
  • Lot SY24K01 and SY24K02 with Exp 09/30/2026
  • Distributors: Rugby Laboratories and Walgreens

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
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
SY24K01
SY24K02
Affected States
ALL
Report Date
April 8, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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