Recalls / Class II
Class IID-0398-2026
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
- Brand name
- Dexamethasone Sodium Phosphate
- Generic name
- Dexamethasone Sodium Phosphate
- Active ingredient
- Dexamethasone Sodium Phosphate
- Route
- Intramuscular, Intravenous
- NDC
- 70069-025
- FDA application
- ANDA211036
- Affected lot / code info
- Lot #: A240421, Exp 07/31/2026
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.
Recalling firm
- Firm
- SOMERSET THERAPEUTICS LLC
- Manufacturer
- Somerset Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Franklin Square Dr, N/A, Somerset, New Jersey 08873-4187
Distribution
- Quantity
- 62190 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2026-02-04
- FDA classified
- 2026-03-18
- Posted by FDA
- 2026-03-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0398-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.