Sunny Pharmtech voluntarily recalls three lots of cyclophosphamide injection after steel particles found

Sunny Pharmtech, Inc. announced a voluntary nationwide recall of three lots of cyclophosphamide for injection, USP, in 1‑gram and 2‑gram vials. The recall was triggered by the detection of steel particulate matter in the product.

The company stated that the recall is being issued to the user level, meaning all downstream customers must return the affected lots. To date, no adverse events or injuries have been reported in connection with the contamination.

Sunny Pharmtech warned that if patients receive the contaminated product, there is a reasonable probability of serious adverse events, including phlebitis, granuloma, occlusion, or life‑threatening thromboembolic events, especially in cancer patients who are often immunosuppressed.

The recall affects the use of cyclophosphamide, a chemotherapy agent indicated for a range of malignant diseases such as lymphomas, multiple myeloma, and leukemias.