Cyclophosphamide Injection Recalled Due to the Presence of Steel Particles
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class I recall for cyclophosphamide injection, 1 g/vial and 2 g/vial. The affected batches have been identified as Lots C23019V1 (expires October 2026), C24015V1 (expires April 2027), and V24010V1 (expires March 2027), affecting 5541 vials.
- The recall was initiated by Sunny Pharmtech, Inc due to the presence of particulate matter, a quality issue that is likely to cause serious adverse health consequences or death.
- Cyclophosphamide is used in treatments for various cancers. It can also be used to treat nephrotic syndrome. The FDA has issued a Class I recall for cyclophosphamide injection, 1 g/vial and 2 g/vial, affecting 5541 vials.
This product is being recalled by Sunny Pharmtech, Inc based in Taoyuan City, Taiwan. The recall was initiated on July 17, 2026, and received a Class I classification on August 8, 2026. A Class I classification means the use of this product is likely to cause serious adverse health consequences or death.
The recall was initiated due to the presence of stainless-steel particles in the product. This deficiency affects Lot C23019V1 (expires October 2026), C24015V1 (expires April 2027), and V24010V1 (expires March 2027). Sunny Pharmtech, Inc sent out a public notice via letter; a press release was issued on July 24, 2026.
Cyclophosphamide is a prescription medication used to treat various cancers such as Hodgkin and non-Hodgkin lymphoma, mycosis fungoides, multiple myeloma, certain types of leukemia, ovarian cancer, breast cancer, retinoblastoma, and neuroblastoma. It can also be used to treat types of kidney disease, including nephrotic syndrome. Pharmacists should identify and quarantine the affected lots, remove them from inventory, and coordinate with prescribers to provide an alternative supply.
References
- FDA. Enforcement Report. August 12, 2026. Accessed August 12, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221553
- FDA. Enforcement Report. August 12, 2026. Accessed August 12, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221554
