Pfizer Inc. recalls Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira,
Pfizer recalls Argatroban injection vials due to impurities and stability issues. Patients with blood clotting conditions should contact their doctor immediately.
Recall notice
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Contact the company & request your remedy
What happened, in plain English
Pfizer is recalling Argatroban injection vials that may contain impurities or degrade over time. This could cause serious health risks for patients using the medication for blood clotting. Read more at govinfonow.com/recall/39672-pfizer-argatroban-injection-recall-impurities-risk-serious-health-effects.
Source Summary by GovInfoNow · govinfonow.com/recall/39672-pfizer-argatroban-injection-recall-impurities-risk-serious-health-effects · Updated October 6, 2026 · FDA enforcement record: FDA #D-1184-2018
Cite this page
“Pfizer Argatroban Injection Recall: Impurities Risk Serious Health Effects.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39672-pfizer-argatroban-injection-recall-impurities-risk-serious-health-effects. Based on FDA recall #D-1184-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1184-2018%22&limit=1).
Why it’s dangerous
The injection vials failed stability testing at 18 months, indicating potential impurities or degradation. This could lead to unsafe medication levels when administered to patients.
Who’s affected
Patients prescribed Argatroban injection for blood clotting conditions are at risk. Healthcare providers using the product for medical treatment may also be affected.
How to tell if you have this one
Check for vials labeled 'Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile'. The NDC code is 0409-1140-01 with lot number DP602 from October 2018.
- Brand
Pfizer- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 0409-1140-01 and lot number DP602 on the vial label.
Questions people ask
Is this product safe to use?
The recall indicates potential impurities or degradation, so it is not safe to use. Patients should contact their doctor immediately.
What should I do if I have this product?
The recall does not specify a remedy, so contact your healthcare provider for guidance.
How can I tell if I have the recalled product?
Check for vials with NDC code 0409-1140-01 and lot number DP602 from October 2018.
Contact Pfizer
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-1184-2018 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-1184-2018 from Pfizer. 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-1184-2018 (August 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1184-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.