Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL) recall
FDA recall D-0651-2025 · initiated Sep 5, 2025
Sandoz Inc recalled Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL) in Sep 2025 — an FDA Class II recall (D-0651-2025) because cGMP deviations: Temperature excursion during transportation.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP deviations: Temperature excursion during transportation.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6 vials
Details
- 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.
- Recalling company
- Sandoz Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Sep 5, 2025
- FDA report date
- Sep 24, 2025
Frequently asked
- Was Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL) recalled?
- Sandoz Inc recalled Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL) in Sep 2025 — an FDA Class II recall (D-0651-2025) because cGMP deviations: Temperature excursion during transportation. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL) recalled?
- Per the FDA enforcement record, the reason for recall D-0651-2025 was: cGMP deviations: Temperature excursion during transportation.
- Is a recalled Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL) are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — 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. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0651-2025.