Cyclophosphamide Injection 500 mg/ recalled over manufacturing violations

Recall date

September 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sandoz Inc recalls Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactu…

Recall number

D-0651-2025

FDA classification

Class II

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

cGMP deviations: Temperature excursion during transportation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.