CLASS II ONGOING Drug recall · Reported 24 Sep 2025 · FDA Enforcement Report
Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalled
Sandoz is recalling Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug, distributed nationwide in the US. The recall was initiated on 5 Sep 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0651-2025
- FDA event ID
- 97549
- Recalling firm
- Sandoz, Princeton, NJ
- Brand
- Cyclophosphamide
- Manufacturer
- Sandoz Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Sep 2025
- FDA classified
- 15 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Sep 2025 | Recall initiated by company | |
| 15 Sep 2025 | Classified by FDA | +10 days |
| 24 Sep 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations: Temperature excursion during transportation.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
cGMP deviations: Temperature excursion during transportation.
Which lots are affected?
Only 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 was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Cyclophosphamide recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled | Sunny Pharmtech | Particulate Matter | Nationwide |
| Drug | CLASS I | Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled | Sunny Pharmtech | Particulate Matter | Nationwide |
| Drug | CLASS III | Cyclophosphamide for Injection, USP, 500mg/vial recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Cyclophosphamide for Injection, USP, Lyophilized recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Cyclophosphamide 840 MG / NS IVPB recalled by Infusion Options | Infusion Options | Sterility | NY |