Hospira Fentanyl Injection Recall: Broken Ampule Tips Risk Infection
Hospira recalls fentanyl injections with broken ampule tips that may cause infection. Affected lots from 2017-11-01 have a risk of contamination. Stop using immediately.
Use caution until it’s fixed
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
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What happened, in plain English
Hospira is recalling fentanyl injections that have broken ampule tips, which could lead to infection. This recall affects specific lots manufactured in 2017 with expiration dates up to November 1, 2017. Read more at govinfonow.com/recall/42267-hospira-fentanyl-injection-recall-broken-ampule-tips-risk-infection.
Source Summary by GovInfoNow · govinfonow.com/recall/42267-hospira-fentanyl-injection-recall-broken-ampule-tips-risk-infection · Updated October 9, 2026 · FDA enforcement record: FDA #D-0153-2017
Cite this page
“Hospira Fentanyl Injection Recall: Broken Ampule Tips Risk Infection.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42267-hospira-fentanyl-injection-recall-broken-ampule-tips-risk-infection. Based on FDA recall #D-0153-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0153-2017%22&limit=1).
Why it’s dangerous
Broken ampule tips can cause contamination during injection, potentially leading to infections. The hazard is related to the product's design and not normal use conditions.
Who’s affected
Healthcare professionals using fentanyl injections for medical purposes. Patients receiving these injections are at risk if they use the recalled products.
How to tell if you have this one
Check for the lot numbers 59277EV, 60028EV, or 6008EV with expiration dates up to November 1, 2017. The product is labeled as Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/2mL.
- Brand
Hospira- Category
Drug
What to do — step by step
Check Product Lot Number
Look for lot numbers 59277EV, 60028EV, or 6008EV on the product label.
Stop Using Immediately
If you have the recalled lot numbers, stop using the product immediately to avoid infection risks.
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 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0153-2017 (November 1, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0153-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.