HIGHFDA DRUG

Fresenius Kabi Compounding Recalls Acyclovir Sodium Injection Due to Sterility Risks

Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.

Official notice

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
Intravenous Injection
Model numbers
Lot # C274-000049124, Exp Date: 28-Feb-26.
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

Acyclovir Sodium Injection is used for treating viral infections, particularly those caused by herpes viruses. It is commonly administered in hospital settings for patients requiring intravenous antiviral therapy.

Why This Is Dangerous

The product's lack of assurance of sterility means it could be contaminated, posing a risk of infection upon administration. Sterile conditions are critical for intravenous medications to prevent serious health complications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers and healthcare providers must act quickly to prevent potential health risks from using this non-sterile product. The urgency is heightened given the serious implications of infection from contaminated injections.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the product packaging to see if it matches C274-000049124.
  2. Verify the expiration date, which is February 28, 2026.
  3. Consult with your healthcare provider if you are unsure.

Where to find product info

The lot number and expiration date can typically be found on the product's outer packaging or label.

What timeline to expect

Expect a refund processing timeline of approximately 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Follow up with Fresenius Kabi Compounding if you do not receive a response within a reasonable timeframe.
  • Document all correspondence and attempts to reach out.

How to prevent similar issues

  • Always check for recalls on medications prior to use.
  • Ensure that any injectable medications are sourced from reputable suppliers.
  • Look for signs of tampering or damage to packaging before use.

Documentation advice

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

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Product Details

This recall affects Acyclovir Sodium, 200 mg per 100 mL, packaged in single-use bags. The recalled lot number is C274-000049124, with an expiration date of February 28, 2026. The product was distributed nationwide in the United States.

Key Facts

  • Recall date: February 5, 2026
  • Quantity recalled: 1,057 bags
  • Lot number: C274-000049124
  • Expiration date: February 28, 2026
  • Distributed nationwide in the US

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 TypeIntravenous Injection
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot # C274-000049124
Exp Date: 28-Feb-26.
Affected States
ALL
Report Date
February 18, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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