Cyclophosphamide Injection 500 mg/5 mL — Class II drug recall D-0651-2025
Ongoing recall by Sandoz Inc, reported 2025-09-24, distributed nationwide. cGMP deviations: Temperature excursion during transportation.
| Recall number | D-0651-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2025-09-05 |
| Classified | 2025-09-15 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 6 vials |
| Reason classes | cgmp, temperature control |
| UPC / GTIN / UDI-DI | 00307813528104 |
| NDC | 00781-3528, 00781-3528-10, 00781-3528-75, 00781-3529, 00781-3529-10, 00781-3529-70, 00781-3530, 00781-3530-10, 00781-3530-80 |
| Lot numbers | 110459 |
| Expiration dates | 2027-02-28 |
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 for recall
cGMP deviations: Temperature excursion during transportation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0651-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.