Somerset Therapeutics Dexamethasone Injection Class II Recall

FDA: Drug Recalls Class II

Filed March 25th, 2026

Detected April 7th, 2026

Summary

The FDA issued a Class II recall for Somerset Therapeutics LLC's Dexamethasone Sodium Phosphate Injection (100mg/10mL, 10x10mL vials) after stability testing at product expiry (24 months) revealed out-of-specification impurity levels. The affected impurities are Dexamethasone Sodium Phosphate EP Impurity G and dexamethasone formate. The recall is ongoing and affects nationwide distribution in the USA.

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What changed

Somerset Therapeutics LLC initiated a Class II recall for Dexamethasone Sodium Phosphate Injection, USP (NDC carton: 70069...) after failed long-term stability testing at the 24-month expiry point revealed OOS (Out of Specification) results for two impurities: Dexamethasone Sodium Phosphate EP Impurity G (Impurity RU 49336) and dexamethasone formate. The recall applies to all affected lots distributed nationwide in the USA.\n\nPharmaceutical distributors and healthcare providers should immediately quarantine and discontinue use of any affected product, verify their inventory against FDA recall records, and notify downstream customers. Patients who received this medication should consult their healthcare providers regarding potential effects and alternatives. Companies should coordinate with Somerset Therapeutics for product return and maintain records of recall activities.

What to do next

Verify inventory against affected lot numbers listed in FDA recall D-0398-2026 and quarantine any affected product immediately
Notify downstream customers and healthcare providers about the recall and product discontinuation
Report any adverse events potentially associated with the recalled medication to FDA MedWatch

Source document (simplified)

SOMERSET THERAPEUTICS LLC

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0398-2026 · 20260325 · Ongoing

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...

Reason for Recall

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.