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.

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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Product Details

The affected product is vancomycin HCl, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP. It was distributed nationwide in the United States and has the NDC 71506-016-59. The lot number is C274-000049628, with an expiration date of May 3, 2026.

The Hazard

The recalled vancomycin injection poses a high risk due to a lack of assurance of sterility. The absence of proper sterilization techniques can lead to serious infections in patients.

Reported Incidents

No specific incidents have been reported. However, the potential for infection from a non-sterile product is significant.

What to Do

Stop using the vancomycin injection immediately. Contact Fresenius Kabi Compounding or your healthcare provider for further guidance.

Contact Information

For more information, visit the FDA recall page or contact Fresenius Kabi Compounding directly for assistance.

Key Facts

  • Recalled product: Vancomycin HCl Injection
  • Total units recalled: 1,578 bags
  • Reason for recall: Lack of assurance of sterility
  • Recall classification: Class II
  • Expiration date: May 3, 2026

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
Lot # C274-000049628
Exp Date: 3-May-26.
Affected States
ALL
Report Date
February 18, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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