FDA warns – 2 lots of Docetaxel Injection, USP recalled by Sagent Pharmaceuticals due to potential trace of particulate matter

Sagent Pharmaceuticals, of Schaumburg, Illinois, has voluntarily recalled two lots of Docetaxel Injection, USP, in 80 mg per 8 mL multi-dose vials as well as in 160 mg per 16 mL multi-dose vials, because particulate matter may be found in the stopper of the product.

The company announced the firm announced the nationwide, user-level recall on May 28, 2024 after receiving a customer complaint.

Users are warned that in the event that an injectable product containing particulate matter is administered intravenously, major adverse events may occur. Complications may include “inflammation of a vein, granuloma”, and blood vessels in the heart, lungs, or brain being blocked, which could lead to a stroke or other “life-threatening blood clot events.”

A variety of factors may put certain patients at risk of more frequent and severe adverse events: the size and amount of particles found in the drug, co-morbidities like age or compromised function of an organ, as well as the presence of vascular anomalies.

While Sagent Pharmaceuticals has not been notified of any adverse reactions in connection to the recall, consumers are urged to be aware of the following affected lot numbers, expiration dates, and NDC numbers of the Docetaxel Injection, USP:

  • Docetaxel Injection, USP
    • Lot Numbers: F1030001, F1040001
    • NDCs: 25021-254-16, 25021-254-08
    • Expiration Dates: 12/2024, 12/2024
    • Strengths: 160 mg/16 mL(10 mg/mL), 80 mg/8 mL(10 mg/mL)

Shortly after the recall was initiated, customers were sent a FedEx package with instructions on how to arrange for a return of all recall product. The following requests were also made:

  • Evaluate inventory and quarantine any remaining affected products
  • Discontinue distribution of all recalled lots and arrange for their return
  • Ensure that anyone who may have received a sub-distribution of the recalled products is alerted
  • All consumers, distributors, and retailers of the product should cease all use of the product and have it returned
  • Visit www.sagentpharma.com to find the necessary form to document recall-related information

Those with questions about the return program should contact the company’s customer call center at (866) 625-1618, Option 1, on Monday through Friday, from 8:00 a.m. to 5:00 p.m. Central Time, option 1.

Healthcare professionals seeking medical information about Docetaxel Injection, USP can reach Medical Affairs at (866) 625-1618, Option 3. Representatives are available Monday through Friday, from 8:00 a.m. to 5:00 p.m. Central Time.

Consumers experiencing problems believed to be related to use of the product should consult their physician or healthcare provider.

The FDA urges that all adverse reactions or quality issues be reported to its MedWatch Adverse Event Reporting program.


Our compassionate team at TruLaw is personally invested in connecting you and your family with the legal representation you deserve after a traumatic medical event caused by another party. If you were injured or are suffering an adverse health outcome due to the use of a contaminated medical device, our attorneys are prepared to help you build a case for maximum compensation. Contact us online or take our free Instant Case Evaluation ℠  to learn more.