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.
Recall at a glance
- Quantity recalled
- 62190 vials
Why it was recalled
Somerset Therapeutics is recalling Dexamethasone Sodium Phosphate Injection, USP, 100 mg/10 mL (10 mg/mL) in 10×10 mL multiple-dose vials (NDC carton 70069-025-10; NDC vial 70069-025-01) due to out-of-specification impurities detected at product expiry. Long-term stability testing revealed elevated levels of Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate above acceptable limits.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Dexamethasone Sodium Phosphate Injection, USP
- Strength
- 100 mg
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification