Class IIReported 2025-09-24

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.

Recalled by Sandoz Inc

Reason for Recall

cGMP deviations: Temperature excursion during transportation.

Recall Number

D-0651-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-09-05

Reported

2025-09-24

Distribution

Nationwide in the USA

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.