HIGHFDA DRUG

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Official notice
Fresenius Kabi CompoundingHealth & Personal CareDrugs & MedicationsLot # C274-000047611Exp Date: 10-Feb-26Lot # C274-000049633

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
Unknown
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
Vancomycin Injection
Model numbers
Lot # C274-000047611, Exp Date: 10-Feb-26, Lot # C274-000049633, Exp Date: 12-May-26.
Sold at
Unknown
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

Vancomycin HCl injection is a vital antibiotic used in hospitals to treat severe bacterial infections. Healthcare providers often rely on its efficacy for patients with resistant infections.

Why This Is Dangerous

The recall is due to a lack of assurance of sterility, which means the product may be contaminated. Contaminated injections can lead to severe infections if administered.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers must stop using this product immediately to avoid potential health risks. The recall underscores the importance of sterility in injectable medications.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the product packaging.
  2. Verify the expiration date against the recalled lots.
  3. Contact your healthcare provider for confirmation.

Where to find product info

Lot numbers are typically printed on the label or packaging of the injection.

What timeline to expect

Expect about 4-6 weeks for refunds or replacements after initiating contact.

If the manufacturer is unresponsive

  • Follow up with customer service through email or phone.
  • Document all correspondence for reference.

How to prevent similar issues

  • Always check for recall notices on medications before use.
  • Inquire about the sterility assurance of injectable products during purchase.

Documentation advice

Keep records of the product, including photos of the lot number and any correspondence with the manufacturer.

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Product Details

The recalled product is vancomycin HCl, 2 grams, added to 500 mL of 0.9% Sodium Chloride Injection. Model numbers include Lot # C274-000047611 (Exp Date: 10-Feb-26) and Lot # C274-000049633 (Exp Date: 12-May-26).

Key Facts

  • Recalled product: Vancomycin HCl Injection
  • Classification: Class II
  • Recall date: February 5, 2026
  • Contact Fresenius Kabi for guidance

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
Lot # C274-000047611
Exp Date: 10-Feb-26
Lot # C274-000049633
Exp Date: 12-May-26.
Affected States
ALL
Report Date
February 18, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

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.

Fresenius Kabi Compounding
Lack of
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