FDA-PR2026-07-24PROCESSING DEFECT

Sunny Pharmtech Cyclophosphamide for Injection recalled for steel particulate matter

METALNationwide distribution

Sunny Pharmtech Cyclophosphamide recalled for steel particles

Sunny Pharmtech is recalling three lots of Cyclophosphamide for Injection (1g and 2g vials) distributed between May 2024 and October 2024 because steel particles were found in the product. No injuries have been reported so far, but steel particles in an intravenous injection could cause serious complications including blood clots and infection.

  • If you are a pharmacy, hospital, or healthcare provider: immediately stop dispensing these lots, quarantine all affected inventory, and contact Cardinal Health to arrange return.
  • If you have received this medication, contact your healthcare provider or Sunny Pharmtech at 886-3-4809168 ext. 7205 (Monday–Friday, 9 AM–5 PM GMT+8) or ra@sunnypharmtech.com.
  • Do not stop your cancer treatment without consulting your doctor.
  • Report any problems to FDA MedWatch at www.fda.gov/medwatch or 1-800-332-1088.

Product photos

Label, Cyclophosphamide for Injection, USP 1 gram/vial
Label, Cyclophosphamide for Injection, USP 1 gram/vial
Label, Cyclophosphamide for Injection, USP 2 gram/vial
Label, Cyclophosphamide for Injection, USP 2 gram/vial
Hazard

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 pa

Official notice

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunny-pharmtech-inc-issues-voluntary-nationwide-recall-cyclophosphamide-injection-usp-user-level-due

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