HIGHFDA DRUG

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.

Official notice
Fresenius Kabi CompoundingHealth & Personal CareDrugs & MedicationsLot # C274-000047883Exp Date: 17-Feb-26Lot # C274-000048515

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
February 5, 2026
Status
ACTIVE
Severity
8/10

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

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
Fresenius Kabi Compounding
Product type
Sodium Chloride Injection
Model numbers
Lot # C274-000047883, Exp Date: 17-Feb-26, Lot # C274-000048515, Exp Date: 22-Mar-26, Lot # C274-000048679, Exp Date: 31-Mar-26, Lot # C274-000049119, Exp Date: 19-Apr-26 +2 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    February 5, 2026

  2. Reported by FDA DRUG

    February 18, 2026

  3. RecallRadar source check

    February 25, 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 Fresenius Kabi Compounding, LLC or your healthcare provider for guidance. Notification method: Letter

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.

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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
  • Lack of sterility assurance
  • Class II recall

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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Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

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