FDA - Food and Drug Administration

07/24/2026 | Press release | Distributed by Public on 07/24/2026 09:47

Long Grove Pharmaceuticals (Cyclophosphamide for Injection/Sunny Pharmtech, Inc.) Recall reason: Presence of particulate matter identified as steel

COMPANY ANNOUNCEMENT

Sunny Pharmtech, Inc. Issues Voluntary Nationwide Recall of Cyclophosphamide for Injection, USP to the User Level Due to the Presence of Particulate Matter

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date: July 24, 2026 FDA Publish Date: July 24, 2026 Product Type: Drugs Reason for Announcement:
Recall Reason Description
Presence of particulate matter identified as steel
Company Name: Sunny Pharmtech, Inc. Brand Name:
Brand Name(s)
Long Grove Pharmaceuticals
Product Description:
Product Description
Cyclophosphamide for Injection

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 [email protected], 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.

Company Contact Information

Consumers: (886) 3-4809168 [email protected]

Product Photos

FDA - Food and Drug Administration published this content on July 24, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on July 24, 2026 at 15:47 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]