Drug recall
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx…
FDA recall event 98388 · Class II · SOMERSET THERAPEUTICS LLC
Key facts
| Event ID | 98388 |
|---|---|
| Recall numbers | D-0398-2026 |
| Recalling firm | SOMERSET THERAPEUTICS LLC |
| Product type | Drugs |
| 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| 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… |
| Initiation date | Feb 4, 2026 |
| Report date | Mar 25, 2026 |
| City | Somerset |
| State | NJ |
| Country | United States |
| FEI number | 3013895162 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: