Class I · High risk
Magnesium Sulfate in Water for Injection
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Magnesium Chloride
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1
Affected NDC
10106-2448-01
Compare with the code on your package — it is the most precise check available.
Drug: Magnesium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Magnesium Chloride, 6-Hydrate NDC 10106-2448 |
MAGNESIUM CHLORIDE 1 kg/kg | Crystal | Avantor Performance Materials, LLC | BULK INGREDIENT |
- Recalling firm
- Avantor Performance Materials LLC
- NDC code
- 10106-2448-1
- Origin
- KY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0488-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Magnesium recalls
See all
Class II · Moderate risk
INON ACE Antacid tablets
Failed Disintegration Specifications: above the time expected.
Class II · Moderate risk
Magnesium Chloride for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione Magnesium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Other recalls by Avantor Performance Materials LLC
All 2026 recalls
Class II · Moderate risk
Potassium Phosphate
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Class III · Low risk
Magnesium Sulfate 7-Hydrate
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
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