Sunny Pharmtech Recalls Cyclophosphamide Vials Due to Steel Particulates

Oncology nurses and infusion center staff are being alerted to a significant voluntary nationwide recall of three lots of Cyclophosphamide for Injection, USP, distributed by Sunny Pharmtech, Inc.

The recall, which includes both 1 g/vial and 2 g/vial dosages, was initiated following the discovery of particulate matter identified as steel within the vials. While the manufacturer reports that no adverse events have been documented to date, the clinical risks associated with the administration of contaminated intravenous products are severe, particularly for the oncology population.

Clinical Risks and Patient Vulnerability

The presence of foreign particulate matter in an injectable medication presents a "reasonable probability" for serious adverse events, including mortality, should the product be administered intravenously. For patients receiving treatment for cancer, these risks are compounded by pre-existing comorbidities, immunosuppression resulting from prior or current therapies, and potential nutritional deficiencies.

If steel particulates are introduced into the bloodstream, patients may experience a range of complications, including:

• Phlebitis (inflammation of the vein).
• Granuloma (localized inflammatory nodules).
• Vascular occlusion.
• Life-threatening thromboembolic events.

Given the systemic nature of cyclophosphamide administration, oncology nurses must remain vigilant for signs of infusion-related complications in patients who may have recently received medication from the affected lots.

Scope of the Recall

The recalled products were distributed to wholesalers, hospitals, pharmacies, and distributors across the United States between May 2024 and October 2024. The affected vials are marketed under the brand name Long Grove Pharmaceuticals.

The specific lots and National Drug Code (NDC) numbers included in this action are as follows:

• Cyclophosphamide for Injection, USP, 1 g/vial (50 mL vial): NDC 81298-8112-1; Lot numbers C23019V1 (Exp. Oct-2026) and C24015V1 (Exp. Apr-2027).
• Cyclophosphamide for Injection, USP, 2 g/vial (100 mL vial): NDC 81298-8114-1; Lot number V24010V1 (Exp. Mar-2027).

This medication is a cornerstone in the treatment of a wide array of malignant diseases, including malignant lymphomas (such as Hodgkin disease and Burkitt’s lymphoma), multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, and breast carcinoma.

Additionally, it is utilized in pediatric patients for biopsy-proven minimal change nephrotic syndrome when corticosteroid therapy has failed or is not tolerated.

Required Actions for Healthcare Providers

Sunny Pharmtech, in coordination with the U.S. Food and Drug Administration (FDA) and distributor Cardinal Health, is currently managing the return and destruction of the compromised lots.

Oncology nurses and facility managers are advised to take the following steps immediately:

• Inventory Audit: Check all current stock against the NDC and lot numbers listed above.
• Quarantine: Immediately stop the use and dispensing of any product identified from the recalled lots.
• Coordination: Follow the specific instructions provided in the recall notification for returning affected inventory to Cardinal Health for reconciliation and destruction.
• Patient Consultation: Patients should be advised not to discontinue or alter their prescribed treatment without first consulting their healthcare provider.

Reporting Adverse Events

Healthcare professionals and patients are encouraged to report any adverse reactions or quality issues to the FDA’s MedWatch Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/medwatch/report.htm, via regular mail using Form FDA 3500, or by faxing the completed form to 1-800-FDA-0178.For additional inquiries regarding this recall, Sunny Pharmtech, Inc. can be reached directly at 886-3-4809168, Ext. 7205, or via email at [email protected] during business hours.

This recall underscores the critical role of oncology nurses in the final stage of the medication safety chain, ensuring that contaminated products do not reach the vulnerable patients under their care.

Reference

Sunny Pharmtech, Inc. Issues Voluntary Nationwide Recall of Cyclophosphamide for Injection, USP to the User Level Due to the Presence of Particulate Matter. U.S. Food and Drug Administration. July 24, 2026. Accessed July 28, 2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunny-pharmtech-inc-issues-voluntary-nationwide-recall-cyclophosphamide-injection-usp-user-level-due