Sandoz Cyclophosphamide Injection Recall: Temperature Excursion Risk
Sandoz recalls specific lots of Cyclophosphamide Injection due to temperature issues during shipping that could affect drug safety.
Lower-risk recall
cGMP deviations: Temperature excursion during transportation.
Contact the company
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. Read more at govinfonow.com/recall/31801-sandoz-cyclophosphamide-injection-recall-temperature-excursion-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31801-sandoz-cyclophosphamide-injection-recall-temperature-excursion-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0651-2025
Cite this page
“Sandoz Cyclophosphamide Injection Recall: Temperature Excursion Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31801-sandoz-cyclophosphamide-injection-recall-temperature-excursion-risk. Based on FDA recall #D-0651-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0651-2025%22&limit=1).
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- Product
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial- Category
Drug
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.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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.