CLASS I Drug recall · Reported 24 Feb 2016 · FDA Enforcement Report
Magnesium Sulfate in Water for Injection recalled by Hospira
Hospira is recalling Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL Total Single-Dose, distributed nationwide in the US. The recall was initiated on 5 Jan 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-0668-2016
- FDA event ID
- 72996
- Recalling firm
- Hospira, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Jan 2016
- FDA classified
- 16 Feb 2016
- Reported
- 24 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Jan 2016 | Recall initiated by company | |
| 16 Feb 2016 | Classified by FDA | +42 days |
| 24 Feb 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
Product as listed by the FDA
Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
Which lots are affected?
Lot: 53-113-JT, Exp 1NOV2016
Where was it sold?
Nationwide
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.
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Other Magnesium recalls
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Magnesium Sulfate in Water for Injection (40mg/mL) IV recalledMagnesium Sulfate | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Meijer Magnesium Citrate Saline Laxative Oral Solution Dye recalledMagnesium Citrate | Pharma Nobis | Sterility | Nationwide |
| Drug | CLASS II | Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral recalledMagnesium Citrate | Pharma Nobis | Sterility | Nationwide |
| Drug | CLASS II | Good Neighbor Pharmacy, Dye Free recalled by Pharma NobisMagnesium Citrate | Pharma Nobis | Sterility | Nationwide |
| Drug | CLASS I | Equaline magnesium citrate saline laxative recalled by Vi-JonCitroma | Vi-Jon | Sterility | Nationwide |