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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 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.
Recall announced
August 29, 2025
Reported by FDA DRUG
September 24, 2025
RecallRadar source check
April 18, 2026
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
- Review model numbers against the 15 listed in the recall data.
- Check lot numbers if provided by the facility.
- 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
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Safety Guide
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