Hospira Argatroban Injection Recall: Impurities Risk Serious Health Effects
Hospira recalls Argatroban Injection vials with potential impurities that could cause serious health risks. Affected units have specific NDC and lot numbers. Contact Hospira for details.
Recall notice
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Contact the company
What happened, in plain English
Hospira is recalling Argatroban Injection vials due to impurities that may cause serious health issues. This affects specific vials with NDC 0409-1140-01 and lot number DP601. Patients using this medication should contact Hospira for guidance. Read more at govinfonow.com/recall/41512-hospira-argatroban-injection-recall-impurities-risk-serious-health-effects.
Source Summary by GovInfoNow · govinfonow.com/recall/41512-hospira-argatroban-injection-recall-impurities-risk-serious-health-effects · Updated October 8, 2026 · FDA enforcement record: FDA #D-0980-2017
Cite this page
“Hospira Argatroban Injection Recall: Impurities Risk Serious Health Effects.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41512-hospira-argatroban-injection-recall-impurities-risk-serious-health-effects. Based on FDA recall #D-0980-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0980-2017%22&limit=1).
Why it’s dangerous
The vials may contain impurities that could cause serious health effects. The impurities were detected during testing but the exact health risk is not specified in the recall notice.
Who’s affected
Patients prescribed Argatroban Injection by a healthcare provider. Those using the specific vial model with NDC 0409-1140-01 and lot DP601 are most at risk.
How to tell if you have this one
Check for the NDC code 0409-1140-01 and lot number DP601 on the vial label. The product is a 5 mL single-use vial for prescription use only.
- Brand
Hospira- Category
Drug
What to do — step by step
Check Vial Label
Look for NDC code 0409-1140-01 and lot number DP601 on the vial label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0980-2017 (July 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0980-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.