Hospira Recalls Magnesium Sulfate Vials Due to Particulate Matter
Hospira Inc. recalls specific lots of Magnesium Sulfate Inj., USP 50% due to confirmed particulate matter. Check your vials immediately.
Stop using this now
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
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What happened, in plain English
Hospira Inc. is recalling Magnesium Sulfate Injection, USP 50% (10 g/20 mL) single-dose vials because of a confirmed customer complaint regarding the presence of particulate matter in the solution. This Class I recall affects approximately 88,500 vials distributed nationwide and in the United Arab Emirates, Kuwait, and Bahrain. The specific lots involved are identified by lot number 50-343-DK followed by numbers 01 to 99. Read more at govinfonow.com/recall/43102-hospira-recalls-magnesium-sulfate-vials-due-to-particulate-matter.
Source Summary by GovInfoNow · govinfonow.com/recall/43102-hospira-recalls-magnesium-sulfate-vials-due-to-particulate-matter · Updated October 11, 2026 · FDA enforcement record: FDA #D-1137-2016
Cite this page
“Hospira Recalls Magnesium Sulfate Vials Due to Particulate Matter.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43102-hospira-recalls-magnesium-sulfate-vials-due-to-particulate-matter. Based on FDA recall #D-1137-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1137-2016%22&limit=1).
Why it’s dangerous
The presence of particulate matter in an injectable drug can pose serious health risks if introduced into the body. While the record does not detail specific injuries, Class I recalls indicate a situation where use could cause serious adverse health consequences or death.
Who’s affected
Patients or healthcare providers who have received or administered Magnesium Sulfate Injection, USP 50% from the recalled lots. Individuals with these vials are at risk of exposure to particulate matter during injection.
How to tell if you have this one
Look for Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL) in 20 mL single-dose vials, packaged in boxes of 25. Check the label for NDC 0409-2168-02 and lot numbers starting with 50-343-DK followed by any number from 01 to 99. The expiration date on these vials is 01FEB2017.
- Brand
Hospira- Category
Drug
What to do — step by step
Stop using the product
Do not use or administer the recalled Magnesium Sulfate vials due to the risk of particulate matter.
Identify your lot number
Check the vial label for lot numbers beginning with 50-343-DK followed by digits 01 through 99.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide, United Arab Emirates, Kuwait, and Bahrain” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
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-1137-2016 (March 23, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1137-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.