Sagent Docetaxel Injection Recall: Particulate Matter Hazard

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Recalling firmSagent Pharmaceuticals1901 N Roselle Rd Ste 450, N/A · Schaumburg, IL 60195

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Sagent Pharmaceuticals is recalling Docetaxel injection vials that may contain particulate matter from the stopper. This could cause serious injury if the vial is injected. Patients should not use these vials.

Why it’s dangerous

Particulate matter in the vial could enter the bloodstream during injection, potentially causing serious injury or death. This is a known risk with certain drug products.

Who’s affected

Patients prescribed Docetaxel injection by a healthcare provider. Those using the recalled vials (NDC 25021-254-08, lot F1040001) are most at risk.

How to tell if you have this one

Check for NDC code 25021-254-08 and lot number F1040001 on the vial. The vial is labeled as 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only.

Brand
Sagent Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Vial Now
Immediately discard the vial if it has NDC 25021-254-08 and lot F1040001.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

No, the product contains particulate matter that could cause serious injury if injected. Do not use.

What should I do if I have this product?

Immediately discard the vial if it has NDC 25021-254-08 and lot F1040001.

How can I check if my vial is recalled?

Look for NDC code 25021-254-08 and lot number F1040001 on the vial label.

Take action

Contact Sagent Pharmaceuticals

We’ve drafted a message you can send Sagent Pharmaceuticals to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0553-2024 — Sagent Pharmaceuticals Sagent Pharmaceuticals

Hello,

I own a Sagent Pharmaceuticals that is covered by recall D-0553-2024 from Sagent Pharmaceuticals.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0553-2024 (May 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0553-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Sagent Pharmaceuticals recalls Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent

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