Dexamethasone Sodium Phosphate Injection, USP 100 mg/10 mL
Somerset Therapeutics is recalling Dexamethasone Sodium Phosphate Injection (NDC 70069-025-10/01) due to out-of-specification impurities at expiry.
Healthcare providers and patients should stop using affected vials immediately. Contact Somerset Therapeutics at the number on the product label or visit the firm's website for instructions on return or disposal. Consult your healthcare provider regarding alternative treatment options.
Why it was recalled
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.
How to identify it
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
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification