CLASS I ONGOING Drug recall · Reported 13 Jul 2016 · FDA Enforcement Report
Magnesium Sulfate Inj., USP 50%/mL) recalled by Hospira
Hospira is recalling Magnesium Sulfate Inj., USP 50%/mL), (4 mEq Magnesium/mL Single-dose vial, distributed nationwide in the US. The recall was initiated on 23 Mar 2016 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1137-2016
- FDA event ID
- 73855
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 23 Mar 2016
- FDA classified
- 6 Jul 2016
- Reported
- 13 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Mar 2016 | Recall initiated by company | |
| 6 Jul 2016 | Classified by FDA | +105 days |
| 13 Jul 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Product as listed by the FDA
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
Where it was distributed
Nationwide, United Arab Emirates, Kuwait, and Bahrain
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Which lots are affected?
Lot #: 50-343-DK*, Exp 01FEB2017; note that the lot number may be followed by numbers from 01 to 99.
Where was it sold?
Nationwide, United Arab Emirates, Kuwait, and Bahrain
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hospira
All 225| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
Other Magnesium Inj recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Magnesium Sulfate Inj., USP 50%/mL) recalled by Hospira | Hospira | Potency & Assay | Nationwide |