FDAFDA · Food and drugs·Recall number D-0398-2026
Dexamethasone 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, NDC carton: 70069-025-10; NDC vial: 70069-025-01
Published March 25, 2026 · Recall initiated: February 4, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DEXAMETHASONE SODIUM PHOSPHATE
- Manufacturer
- SOMERSET THERAPEUTICS LLC
- Distributor
- Nationwide in the USA
- UPC
- 0370069025109
- Lot
- Lot #: A240421, Exp 07/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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