July 24, 2026 – Taoyuan City, Taiwan – Sunny Pharmtech, Inc is voluntarily recalling three lots of Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial, to the User Level due to the presence of particulate matter identified as steel. To date, no adverse events or injuries associated with this particulate matter issue have been reported.

Risk Statement: There is a reasonable probability for serious adverse events, including death, should a patient receive intravenous infusion of product found to contain particulate matter. For the population most at risk, cancer patients who are likely to have numerous pre-existing comorbidities and may be immunosuppressed due to concomitant or prior treatment and nutritional issues related to their cancer, complications can include phlebitis, granuloma, and occlusion or life-threatening thromboembolic events.

Cyclophosphamide for Injection, USP is indicated for treatment of malignant diseases (malignant lymphomas; Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma) and minimal change nephrotic syndrome in pediatric patients (biopsy-proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy).

The affected Product is packaged as 1 g/vial, one 50 mL single-dose vial in a carton (NDC 81298-8112-1) and as a 2 g/vial, one 100 mL single-dose vial in a carton (NDC 81298-8114-1). The affected product was distributed to wholesalers, distributors, hospitals and pharmacies from May 2024 to October 2024 and can be identified using the information below. The three recalled lots (C23019V1, C24015V1, V24010V1) will remain within expiry until October 2026, April 2027, and March 2027, respectively.

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