Class II · ModerateActive recall
Cyclophosphamide
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberOnly the following 6 GTN Numbers for Lot # 110459 exp. date 02/28/2027: (01)00307813528104(21)10686040629319 (01)00307813528104(21)10687281435306 (01)00307813528104(21)10687409963168 (01)00307813528104(21)10701200331212 (01)00307813528104(21)10687325644911 (01)00307813528104(21)10687661160169
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
cGMP deviations: Temperature excursion during transportation.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made bySandoz Inc
| Brand name | CYCLOPHOSPHAMIDE |
| Generic name | CYCLOPHOSPHAMIDE |
| Active ingredient(s) | CYCLOPHOSPHAMIDE |
| Distributed by / for | Sandoz Inc |
| NDC | 0781-3528-75 |
Show the full FDA record
| Full product label | Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10. |
| Recalling firm | Sandoz Inc |
| Distribution | Nationwide in the USA |
| Quantity | 6 vials |
| Recall initiated | 2025-09-05 |
| Report date | 2025-09-24 |
| Recall completed | — |
| Recall number | D-0651-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.