Recall RadarDexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873,…
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- SOMERSET THERAPEUTICS LLC — Somerset, NJ
- Severity
- Class II — moderate
- Reported
- March 25, 2026
- Quantity
- 62190 vials
- Recall number
- D-0398-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide in the USA
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