Cyclophosphamide for Injection

  • Presence of particulate matter identified as steel
  • Company: Sunny Pharmtech, Inc.
  • Drugs
  • FDA
  • July 24, 2026

Product details

  • Cyclophosphamide for Injection

Company announcement

Sunny Pharmtech, Inc. is voluntarily recalling three lots of Cyclophosphamide for Injection, USP nationwide.

The recall, announced on July 24, 2026, is due to the presence of particulate matter identified as steel.

No adverse events or injuries have been reported to date in connection with this issue.

Risk:

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.

Impacted states: Nationwide

Products:

- Cyclophosphamide for Injection, USP 1 g/vial, 50mL vial (UPC code(s): 8129881121)

- Cyclophosphamide for Injection, USP 2 g/vial, 100 mL vial (UPC code(s): 8129881141)

Contact

For more information, call (886) 3-4809168 or email ra@sunnypharmtech.com.

View the original FDA notice

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