SOMERSET THERAPEUTICS LLC recalls Dexamethasone Sodium Phosphate Injection
- Recalling company
- SOMERSET THERAPEUTICS LLC
- Product
- 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
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Feb 4, 2026
- Reported
- Mar 25, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 62190 vials
- Lot / codes
- Lot #: A240421, Exp 07/31/2026
- Company location
- Somerset, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0398-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0398-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.