Class IIOngoing

Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL) recall

FDA recall D-0651-2025 · initiated Sep 5, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

cGMP deviations: Temperature excursion during transportation.

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

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0651-2025 ↗

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