HIGH

Fresenius Kabi Compounding Recalls Ketamine Injection for Sterility Risk

Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.

Quick Facts at a Glance

Recall Date
February 5, 2026
Hazard Level
HIGH
Brand
Fresenius Kabi Compounding
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 Fresenius Kabi Compounding, LLC or your healthcare provider for guidance. Notification method: Letter

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About This Product

Ketamine HCl is commonly used as an anesthetic in medical settings. It is often used in surgery and pain management.

Why This Is Dangerous

The lack of assurance of sterility means that the product could be contaminated, leading to serious infections if administered.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers must act quickly to avoid potential health risks associated with using a contaminated product.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number against the recalled lots listed in the recall notice.
  2. Verify expiration dates to ensure the product is still within the valid range.
  3. Consult with healthcare providers to confirm if you have the affected product.

Where to find product info

Lot numbers and expiration dates can typically be found on the product packaging or label.

What timeline to expect

Expect a timeline of approximately 4-6 weeks for processing refunds or replacements.

If the manufacturer is unresponsive

  • Document all communications with the company regarding the recall.
  • Consider contacting the FDA or other regulatory bodies if there is no response.

How to prevent similar issues

  • Always check for recall notices on medications before use.
  • Look for sterility certifications when purchasing injectable medications.

Documentation advice

Keep records of your purchase, including receipts and correspondence regarding the recall.

Product Details

The recall involves ketamine HCl, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection. The affected lot numbers include C274-000047883, C274-000048515, C274-000048679, C274-000049119, and C274-000049282. The product was distributed nationwide in the U.S.

Key Facts

  • Recall date: February 5, 2026
  • 1,410 bags recalled
  • Lack of sterility assurance
  • Class II recall
  • Distributed nationwide

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 Classification

Product TypeSodium Chloride Injection
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot # C274-000047883
Exp Date: 17-Feb-26
Lot # C274-000048515
Exp Date: 22-Mar-26
Lot # C274-000048679
+5 more
Affected States
ALL
Report Date
February 18, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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