FDA Drug recall D-0651-2025
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fa…
- FDA Drug
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fa… by Sandoz, citing cGMP deviations: Temperature excursion during transportation.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0651-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-05 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sandoz |
| Distribution | US |
Product
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.
Reason
cGMP deviations: Temperature excursion during transportation.
Identifiers
| ndc | 0781-3528-75 |
|---|---|
| ndc | 0781-3528-10 |
| ndc | 0781-3529-70 |
| ndc | 0781-3529-10 |
| ndc | 0781-3530-80 |
| ndc | 0781-3530-10 |
| ndc | 0030781352 |
| ndc | 1068604062 |
| ndc | 1068728143 |
| ndc | 1068740996 |
| ndc | 1070120033 |
| ndc | 1068732564 |
| ndc | 1068766116 |
| code_info | Only the following 6 GTN Numbers for Lot # 110459 exp. date 02/28/2027: (01)00307813528104(21)10686040629319…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0651-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.