HIGHFDA DRUG

Fresenius Kabi Compounding Recalls Thiamine Injection Over Sterility Risk

Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.

Official notice
Fresenius Kabi CompoundingHealth & Personal CareDrugs & MedicationsLot # C274-000047651Exp Date: 7-Feb-26Lot # C274-000048671

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
Thiamine HCl Injection
Model numbers
Lot # C274-000047651, Exp Date: 7-Feb-26, Lot # C274-000048671, Exp Date: 30-Mar-26, Lot # C274-000048828, Exp Date: 7-Apr-26, Lot # C274-000049121, Exp Date: 19-Apr-26 +12 more
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

Thiamine HCl Injection is used to treat thiamine deficiency and is commonly administered in clinical settings. Healthcare providers often use it in patients who require supplemental thiamine, especially those with certain medical conditions.

Why This Is Dangerous

The lack of assurance of sterility means that the injection could be contaminated, leading to potential infections or adverse health effects for patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers and healthcare providers must act quickly to stop using the affected product to avoid serious health risks.

Practical Guidance

How to identify if yours is affected

  1. Locate the lot number printed on the product packaging.
  2. Check the expiration date to determine if your product is affected.
  3. Refer to the recall announcement for the complete list of affected lots.

Where to find product info

The lot number and expiration date are typically found on the label of the product packaging.

What timeline to expect

Refund processing may take 4-6 weeks after the return of the recalled product.

If the manufacturer is unresponsive

  • Document all communications with the company regarding the recall.
  • Contact the FDA to report unresponsiveness or concerns.
  • Consider consulting a legal professional if serious health issues arise.

How to prevent similar issues

  • Always check for recall announcements before using medications.
  • Ensure that injectable products are from reputable manufacturers with good safety records.
  • Ask your healthcare provider about the sterility and safety of any injectable medications.

Documentation advice

Keep a record of the lot number, expiration date, and any correspondence regarding the recall.

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Product Details

The recall involves thiamine HCl, 500 mg added to 100 mL of 0.9% Sodium Chloride Injection, USP. The affected lot numbers include C274-000047651, C274-000048671, C274-000048828, among others. The product was distributed nationwide in the U.S.

Key Facts

  • Recall date: February 5, 2026
  • Quantity recalled: 10,548 bags
  • High hazard level due to sterility risk
  • Affected lots have expiration dates between February and May 2026
  • Nationwide distribution in the U.S.

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 Details

Model Numbers
Lot # C274-000047651
Exp Date: 7-Feb-26
Lot # C274-000048671
Exp Date: 30-Mar-26
Lot # C274-000048828
+15 more
Affected States
ALL
Report Date
February 18, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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