CLASS I Drug recall · Reported 4 Sep 2013 · FDA Enforcement Report
Magnesium Sulfate Injection, USP, 50%, For IM or IV Use recalled
Fresenius Kabi USA is recalling Magnesium Sulfate Injection, USP, 50%, For IM or IV Use, Single Dose Vial, distributed nationwide in the US. The recall was initiated on 25 May 2013 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-920-2013
- FDA event ID
- 65218
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 25 May 2013
- FDA classified
- 23 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 25 May 2013 | Recall initiated by company | |
| 23 Aug 2013 | Classified by FDA | +90 days |
| 4 Sep 2013 | Published in enforcement report | +12 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: Glass particulate matter was observed in a retention sample during an annual review.
Product as listed by the FDA
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Which lots are affected?
Lot #: 6103882, Exp 10/14
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.
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
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 |