CLASS II Drug recall · Reported 17 Oct 2018 · FDA Enforcement Report
Magnesium Sulfate in Water for Injection recalled by Pfizer
Pfizer 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 3 Oct 2018 and the FDA has classified it as Class II.
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-0015-2019
- FDA event ID
- 81126
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Oct 2018
- FDA classified
- 11 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Oct 2018 | Recall initiated by company | |
| 11 Oct 2018 | Classified by FDA | +8 days |
| 17 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
Which lots are affected?
Lot: 87904FW, Exp. 1MAR2020
Where was it sold?
Nationwide in the USA and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 |