Hospira Magnesium Sulfate Recall: Failed pH Specs
Hospira recalls specific lots of Magnesium Sulfate Injection USP due to failed pH specifications. Check your vial lot numbers and expiration dates for details.
Recall notice
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Contact the company
What happened, in plain English
Hospira Inc. is recalling specific lots of Magnesium Sulfate Inj., USP 50% because the product's pH levels were found to be out of specification. The recall affects approximately 715,200 vials distributed nationwide and internationally. No remedy or action steps are currently listed in the record. Read more at govinfonow.com/recall/43105-hospira-magnesium-sulfate-recall-failed-ph-specs.
Source Summary by GovInfoNow · govinfonow.com/recall/43105-hospira-magnesium-sulfate-recall-failed-ph-specs · Updated October 11, 2026 · FDA enforcement record: FDA #D-0854-2016
Cite this page
“Hospira Magnesium Sulfate Recall: Failed pH Specs.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43105-hospira-magnesium-sulfate-recall-failed-ph-specs. Based on FDA recall #D-0854-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0854-2016%22&limit=1).
Why it’s dangerous
The recall was issued because confirmed high out-of-specification results were found for the pH of the injection. The record does not explain how this deviation affects patient safety or clinical outcomes.
Who’s affected
Healthcare providers and patients who have received Magnesium Sulfate Injection USP from the affected lots. The specific health risks to individuals are not described in the provided record.
How to tell if you have this one
Look for single-dose vials labeled Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (4 mEq Magnesium/mL). Check the NDC 0409-2168-02 and barcodes starting with (01) 2 030409 216802. Affected lot numbers include 42-335-DK, 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, 48-351-DK, and 52-361-DK.
- Brand
Hospira- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago” 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 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0854-2016 (March 23, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0854-2016 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.