Sandoz Cyclophosphamide Injection Recall: Temperature Excursion Risk

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Recalling firmSandoz Inc100 College Rd W, N/A · Princeton, NJ 08540-6604

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Sandoz is recalling certain lots of Cyclophosphamide Injection 500 mg/5 mL vials because they may have been exposed to incorrect temperatures during shipping. This could potentially affect the drug's safety and effectiveness.

Why it’s dangerous

The drug may have been exposed to temperatures outside the required range during transportation, which could compromise its sterility and safety. This is a manufacturing issue that affects the product's integrity.

Who’s affected

Healthcare professionals who use the recalled vials for prescription treatments in the U.S. are affected. Patients receiving this medication under a doctor's supervision are at risk if they use the recalled vials.

How to tell if you have this one

Check for the specific GTN numbers listed in the recall notice: (01)00307813528104(21)10686040629319 and other similar codes. The vials were manufactured in Austria and shipped to the U.S. by Sandoz Inc.

Brand
Sandoz
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Vial Details
Look for the GTN numbers listed in the recall notice to confirm if your vial is affected.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall is due to potential temperature issues during shipping, which could affect the drug's safety. Do not use the recalled vials until you confirm they are not affected.

How can I check if my vial is recalled?

Check for the specific GTN numbers listed in the recall notice: (01)00307813528104(21)10686040629319 and other similar codes.

What should I do if I have the recalled vial?

The recall does not specify a remedy, so contact Sandoz Inc for guidance on safe handling or disposal.

Take action

Contact Sandoz

We’ve drafted a message you can send Sandoz to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0651-2025 — Sandoz Sandoz

Hello,

I own a Sandoz that is covered by recall D-0651-2025 from Sandoz.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0651-2025 (September 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0651-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Sandoz Inc recalls Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial,

Lower-risk recall