Quick Facts at a Glance
- Recall Date
- September 5, 2025
- Hazard Level
- HIGH
- Brand
- Sandoz
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
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
- Sandoz
- Product type
- Hazardous drug injection
- Model numbers
- Lot # 110459 exp. date 02/28/2027
- UPC codes
- 0781-3528, 0781-3529, 0781-3530, 0781-3528-75, 0781-3528-10, 0781-3529-70, 0781-3529-10, 0781-3530-80 +1 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 5, 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
cGMP deviations: Temperature excursion during transportation.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Sandoz Inc or your healthcare provider for guidance. Notification method: Letter
About This Product
Cyclophosphamide is a chemotherapy agent used to treat various cancers. It is supplied in vials for hospital or clinic administration.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Healthcare facilities must identify affected lots and replace or refund through the recall process. No injuries have been reported yet.
Practical Guidance
How to identify if yours is affected
- Verify lot number 110459 on the vial
- Check expiration date 02/28/2027
- Cross-check with the FDA recall notice D-0651-2025
Where to find product info
NDC numbers on vial and carton labeling; lot number on vial label
What timeline to expect
Remedy via letter; replacement or refund timelines will be communicated by Sandoz
If the manufacturer is unresponsive
- Document communication attempts
- Contact distributor or healthcare facility regulatory affairs office
- File complaint with FDA if necessary
How to prevent similar issues
- Ensure proper cold-chain handling for hazardous drugs
- Verify lot and expiry during receipt
- Maintain inventory logs for recalls
Documentation advice
Keep the recall notice, lot and NDC details, and correspondence with Sandoz for records
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Product Details
Model numbers: Lot # 110459 exp. date 02/28/2027. Quantity: 263 vials. NDCs: Vial NDC 0781-3528-75, Carton NDC 0781-3528-10. Sold nationwide in the USA. Manufacturer: Fareva Unterach GmbH in Austria for Sandoz Inc., Princeton, NJ 08540. Product category: Cyclophosphamide injectable chemotherapy.
Reported Incidents
No injuries or incidents have been reported in the notice. The recall status remains ACTIVE.
Key Facts
- 263 vials recalled nationwide
- Lot # 110459 exp. date 02/28/2027
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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