CLASS III Drug recall · Reported 27 Jun 2012 · FDA Enforcement Report
Magnesium Sulfate in Water for Injection, 40 mg/mL recalled by Hospira
Hospira is recalling Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL) total Flexible, distributed nationwide in the US. The recall was initiated on 5 Apr 2012 and the FDA has classified it as Class III.
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-1390-2012
- FDA event ID
- 62053
- Recalling firm
- Hospira, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Apr 2012
- FDA classified
- 20 Jun 2012
- Reported
- 27 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Apr 2012 | Recall initiated by company | |
| 20 Jun 2012 | Classified by FDA | +76 days |
| 27 Jun 2012 | 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
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Which lots are affected?
Lot #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 |