FDA Drug Recall Alert – Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial
| Date: | July 09, 2026 |
| From: | Health Plan of San Joaquin/Mountain Valley Health Plan (“Health Plan”) |
| To: | Health Plan Practitioners, Facilities, and Hospitals |
| Type: | Informational/Educational |
| Subject: | FDA Drug Recall Alert – Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial |
| Business: | Medi-Cal Managed Care/Medicare Advantage D-SNP |
On July 24, 2026, the Food and Drug Administration (FDA) released a recall announcement on Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial.
This is for informational purposes only. You may or may not have administered the medication. Please disregard if you have not been affected by this recall.
For the complete details regarding this recall announcement, please visit the following web link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunny-pharmtech-inc-issues-voluntary-nationwide-recall-cyclophosphamide-injection-usp-user-level-due?utm_medium=email&utm_source=govdelivery#recall-announcement
Sunny Pharmtech, Inc. Issues Voluntary Nationwide Recall of Cyclophosphamide for Injection, USP to the User Level Due to the Presence of Particulate Matter
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.
Affected Products
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 | 10/2026 |
| Cyclophosphamide for Injection, USP | 1 g/vial, 50mL vial | 81298-8112-1 | C24015V1 | 04/2027 |
| Cyclophosphamide for Injection, USP | 2 g/vial, 100 mL vial | 81298-8114-1 | V24010V1 | 03/2027 |
What to Do
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.
Contact Information
Sunny Pharmtech, Inc. at 1-886-3-4809168, Ext. 7205 or ra@sunnypharmtech.com
If you have any further questions, please contact your Provider Services Representative, or call our Customer Service Department at 1-888-936-PLAN (7526). You may also visit https://www.hpsj.com/alerts/ for online access to the documents shared. The most recent information about Health Plan and our services is always available on our website www.hpsj-mvhp.org
