Developers at Sunny Pharmtech have issued a voluntary nationwide recall of 3 lots of cyclophosphamide for injection, USP, to the user level because of the presence of particulate matter identified as steel, according to a company announcement posted by the FDA.¹
The recall affects 1-g and 2-g single-dose vials distributed to wholesalers, distributors, hospitals, and pharmacies from May 2024 to October 2024. As of the announcement, no adverse events (AEs) or injuries associated with the particulate matter issue had been reported.
Why was cyclophosphamide for injection recalled?
The recall was initiated because of particulate matter identified as steel found in the affected product. According to the company’s risk statement, there is a reasonable probability of serious AEs, including death, if a patient receives an intravenous infusion of product containing particulate matter. For patients with cancer, who are likely to have numerous preexisting comorbidities and may be immunosuppressed because of concurrent or prior treatment and cancer-related nutritional issues, complications can include phlebitis, granuloma, and occlusion or life-threatening thromboembolic events. No AEs or injuries associated with the issue had been reported as of the announcement date.
Which cyclophosphamide lots are affected by the recall?
The recall covers 3 lots of cyclophosphamide for injection, USP, marketed under the Long Grove Pharmaceuticals brand. The affected products are packaged as 1-g/vial, one 50-mL single-dose vial in a carton (NDC 81298-8112-1), and a 2-g/vial, 100-mL single-dose vial in a carton (NDC 81298-8114-1). The recalled lots are C23019V1 (1 g), which remains within expiry until October 2026; C24015V1 (1 g), which expires in April 2027; and V24010V1 (2 g), which expires in March 2027. The affected product was distributed nationwide from May 2024 to October 2024 through Cardinal Health.
What should pharmacies and providers do?
Pharmacies, hospitals, and other health care providers that have the recalled product should immediately stop use and dispensing, quarantine all affected inventory, and follow the instructions in the recall notification to arrange return of the affected lots to Cardinal Health. Sunny Pharmtech has notified the FDA and Cardinal Health of the recall, and is coordinating with Long Grove Pharmaceuticals and Cardinal Health to notify pharmacies, hospitals, and other providers, and to manage the return, reconciliation, and destruction of the recalled product.
Patients who have questions should contact their physician or health care provider and should not stop or change prescribed treatment without consulting a professional. Adverse reactions or quality problems may be reported to the FDA MedWatch program.
What is cyclophosphamide used to treat?
Cyclophosphamide for injection, USP is indicated for the treatment of malignant diseases, including malignant lymphomas—Hodgkin disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, and Burkitt lymphoma—multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, and breast carcinoma.2 It is also indicated for minimal change nephrotic syndrome in pediatric patients with biopsy-proven disease who have not adequately responded to or cannot tolerate adrenocorticosteroid therapy.
Injectable cyclophosphamide is contraindicated among patients with severely depressed bone marrow function. The agent includes a warning for second malignancies that have developed in patients who received cyclophosphamide alone or in combination with other antineoplastic drugs and/or therapies, including urinary bladder, myeloproliferative, and lymphoproliferative malignancies. Prescribing information also notes that cyclophosphamide may result in fetal harm when given to women who are pregnant. Additionally, male patients who receive cyclophosphamide may experience oligospermia or azoospermia associated with increased gonadotropin but normal testosterone secretion.
References
- Sunny Pharmtech, Inc. issues voluntary nationwide recall of cyclophosphamide for injection, USP to the user level due to the presence of particulate matter. News release. FDA. July 24, 2026. Accessed July 28, 2026. https://tinyurl.com/yxx422cv
- Cyclophosphamide for injection, USP. Prescribing information. FDA; 2012. Accessed July 28, 2026. https://tinyurl.com/4ac3kzbz
