Dexamethasone Sodium Phosphate Injection — Class II drug recall D-0398-2026
Ongoing recall by SOMERSET THERAPEUTICS LLC, reported 2026-03-25, distributed nationwide. Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testi
| Recall number | D-0398-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SOMERSET THERAPEUTICS LLC, Somerset, NJ, United States |
| Recall initiated | 2026-02-04 |
| Classified | 2026-03-18 |
| Reported by FDA | 2026-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 62,190 vials |
| Reason classes | specification failure |
| NDC | 70069-0025, 70069-0025-01, 70069-0025-10 |
| Lot numbers | A240421 |
| Expiration dates | 2026-07-31 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0398-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.