HIGHFDA DRUG

Fagron Compounding Services Bevacizumab Syringe Recall Affects 109,320 Units Nationwide

Fagron Compounding Services recalls 109,320 sterile single-dose bevacizumab syringes nationwide due to lack of assurance of sterility. Healthcare providers and patients should stop using the product immediately. Contact Fagron Compounding Services or a healthcare provider for guidance. The recall was issued on 2025-08-29 and remains active as of 2025-09-24.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
August 29, 2025
Status
ACTIVE
Severity
9/10

Quick Facts at a Glance

Recall Date
August 29, 2025
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
Sterile Single-Dose Syringe
Model numbers
C274-000044756, C274-000044757, C274-000044832, C274-000044833, C274-000044882, C274-000044883, C274-000044972, C274-000045004 +8 more
Sizes
0.12 mL fill
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    August 29, 2025

  2. Reported by FDA DRUG

    September 24, 2025

  3. RecallRadar source check

    April 18, 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 Fagron Compounding Services or your healthcare provider for guidance. Notification method: Letter

About This Product

Bevacizumab is a monoclonal antibody used in oncology as an anti-angiogenic agent. Compounded sterile syringes are prepared for hospital or clinic administration.

Why This Is Dangerous

Lack of sterility assurance can lead to infections or contamination when injected, posing significant health risks.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Immediate action required in clinical settings to prevent potential infections and ensure patient safety.

Practical Guidance

How to identify if yours is affected

  1. Review model numbers against the 15 listed in the recall data.
  2. Check lot numbers if provided by the facility.
  3. Verify fill size is 0.12 mL per syringe.

Where to find product info

Recall notices and model numbers are available via the FDA enforcement page for D-0646-2025 and company communications.

What timeline to expect

Remedy processing timelines are set by the manufacturer and FDA; facilities should expect guidance on refunds or replacements through official notices

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • Notify purchasing department and compliance
  • Contact FDA via Consumer Hotline if the manufacturer is unresponsive

How to prevent similar issues

  • Verify sterility and lot control in compounding suppliers
  • Audit compounding supplier certifications
  • Ensure proper storage and handling of sterile injectable drugs

Documentation advice

Keep recall notices, correspondences, and any affected lot records for compliance and patient safety

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Product Details

Brand: Fagron Compounding Services. Product: Bevacizumab (Avastin) Injection, 1.25 mg/0.05 mL (0.12 mL fill). Type: Sterile Single-Dose Syringe. Distribution: USA nationwide. Quantity: 109,320 syringes. Models involved: see listed model numbers.

Reported Incidents

No specific injuries or incidents are described in the provided data. The status is active with a high hazard classification.

Key Facts

  • Class II recall
  • Lack of Assurance of Sterility
  • Nationwide distribution in the USA
  • Active recall as of 2025-09-24

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
9/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
POISONINGLACERATIONELECTRICALOTHER

Product Details

Model Numbers
C274-000044756
C274-000044757
C274-000044832
C274-000044833
C274-000044882
+11 more
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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