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FDA-Drug2026-03-25Class IICHEMICAL

Somerset Therapeutics dexamethasone injection recalled for impurity levels

Somerset Therapeutics
OTHERNationwide distribution

Stop using Somerset Therapeutics dexamethasone injection

Somerset Therapeutics is recalling one lot of dexamethasone sodium phosphate injection because testing found impurity levels above acceptable limits as the product approached its expiration date. The affected lot (A240421, expiring 07/31/2026) was distributed nationwide. No injuries have been reported.

  • Check your facility's inventory for lot A240421 of Somerset Therapeutics dexamethasone sodium phosphate injection (NDC 70069-025-01 or 70069-025-10)
  • Do not use vials from this lot
  • Contact Somerset Therapeutics or your supplier for return or disposal instructions
  • Consult your pharmacist or healthcare provider if you have questions
Hazard

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.

Sold states
Nationwide in the USA
Affected count
62190 vials
Manufactured in
300 Franklin Square Dr, N/A, Somerset, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0398-2026

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