HIGHFDA DRUG

Fagron Compounding Services Vancomycin HCI Recall: 34,260 Bags with Break-Off-Part Risk (2026)

Fagron Compounding Services recalled 34,260 bags of Vancomycin HCI Injection across the United States. The recall cites lack of sterility assurance and a blue Break-Off-Part that could detach from the administration port. Healthcare providers and patients should stop using the product immediately and follow manufacturer guidance.

Official notice
Fagron Compounding ServicesHealth & Personal CareDrugs & MedicationsLot: C274-000050857Exp.:7/6/2026C274-000049316

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
March 20, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
March 20, 2026
Hazard Level
HIGH
Brand
Fagron Compounding Services
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PETS

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
Fagron Compounding Services
Product type
Vancomycin HCI Injection
Model numbers
Lot: C274-000050857, Exp.:7/6/2026, C274-000049316, Exp.: 4/26/2026, C274-000049367, Exp.: 4/28/2026, C274-000049496, Exp.: 5/3/2026 +12 more
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 20, 2026

  2. Reported by FDA DRUG

    April 15, 2026

  3. RecallRadar source check

    April 22, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Fagron Compounding Services or your healthcare provider for guidance. Notification method: Letter

About This Product

Vancomycin HCI is an antibiotic administered intravenously. This recall involves a compounded sterile product prepared by Fagron Compounding Services for distribution nationwide.

Why This Is Dangerous

A blue Break-Off-Part could detach from the administration port, potentially compromising sterile integrity and allowing contamination.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

High risk for sterile administration products used in clinical settings; delays or substitutions may affect patient care.

Practical Guidance

How to identify if yours is affected

  1. Locate the lot number on the product carton and vial sticker
  2. Cross-check with the FDA recall listing D-0440-2026
  3. Verify expiration date 4/26/2026 through 7/6/2026

Where to find product info

FDA enforcement report D-0440-2026 and recall notification letters

What timeline to expect

Refunds/replacements coordinated by Fagron with healthcare facilities; timelines may vary by institution

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • Contact FDA recalls program for guidance
  • Seek alternative suppliers with proper sterility assurance

How to prevent similar issues

  • Vet compounding suppliers for sterility programs
  • Confirm sterile processing certifications
  • Request lot-level traceability and ensure proper handling

Documentation advice

Keep all recall notices, lot numbers, expiration dates, and correspondence with supplier

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Product Details

Brand: Fagron Compounding Services. Product: Vancomycin HCI, 1.25 g added to 250 mL, 0.9% Sodium Chloride Injection USP. NDC: 71266-5083-01. Quantity: 34,260 bags. Distribution: Nationwide in the USA. Lot numbers and expirations listed in the notice.

Reported Incidents

No specific injuries or incidents are documented in the provided recall notice.

Key Facts

  • Class II recall
  • Nationwide distribution in USA

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
GENERALPREGNANTPETSPREGNANT
Injury Types
POISONINGOTHER

Product Details

Model Numbers
Lot: C274-000050857
Exp.:7/6/2026
C274-000049316
Exp.: 4/26/2026
C274-000049367
+15 more
Affected States
ALL
Report Date
April 15, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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