FDAHealthFebruary 4, 2026
SOMERSET THERAPEUTICS LLC — 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
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 4, 2026
Nationwide in the USA
What's affected?
- 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
- UPC
- 0370069025109
- Lot code
- A240421
Additional details
Lot #: A240421, Exp 07/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 62190 vials.
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