Summary
Company Announcement
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.
| Product Name / Strength | Dosage Form / Package | NDC | Lot Number | Expiration Date |
|---|---|---|---|---|
| Cyclophosphamide for Injection, USP | 1 g/vial, 50mL vial | 81298–8112-1 | C23019V1 | Oct-2026 |
| Cyclophosphamide for Injection, USP | 1 g/vial, 50mL vial | 81298–8112-1 | C24015V1 | Apr-2027 |
| Cyclophosphamide for Injection, USP | 2 g/vial, 100 mL vial | 81298–8114-1 | V24010V1 | Mar-2027 |
Sunny PharmTech has notified FDA and its distributor, Cardinal Health, of this recall action and is coordinating with Long Grove Pharmaceuticals, LLC and Cardinal Health to notify pharmacies, hospitals, and other healthcare providers and to coordinate the return, reconciliation and destruction of the three lots of recalled product in accordance with the recall strategy.
Pharmacies, hospitals, and other healthcare providers that have the recalled product should immediately stop use and dispensing, and quarantine all affected product inventory, and follow the instructions in the recall notification for arranging return of the affected lots to Cardinal Health.
Consumers with questions regarding this recall may contact Sunny Pharmtech, Inc. at 886-3-4809168, Ext. 7205 or ra@sunnypharmtech.com, Monday through Friday from 9AM to 5PM GMT+8. Consumers should contact their physician or healthcare provider if they have experienced any problem that may be related to taking or using this drug product and should not stop or change prescribed treatment without consulting a healthcare professional.
Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting Program as follows:
| Online: | Complete and submit the report at www.fda.gov/medwatch/report.htm |
| Regular Mail: | Download the reporting form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a form; complete and return it to the address on the pre-addressed form. |
| Fax: | Submit the completed form to 1-800-FDA-0178. |
This recall is being conducted with the knowledge of, and in coordination with, the U.S. Food and Drug Administration.
