FDA Drug recall D-0398-2026
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset…
- FDA Drug
- Class II
- ongoing
- Published 2026-03-25
On 2026-03-25 the FDA classified a Class II recall of Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset… by Somerset Therapeutics, citing failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impuritie….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0398-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-04 |
| Published | 2026-03-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Somerset Therapeutics |
| Distribution | US |
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
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.
Identifiers
| ndc | 70069-025-10 |
|---|---|
| ndc | 70069-025-01 |
| code_info | Lot #: A240421, Exp 07/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Somerset Therapeutics
- Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset The…
FDA Drug · Class III · 2025-12-24 · Somerset Therapeutics - Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Th…
FDA Drug · Class III · 2025-12-24 · Somerset Therapeutics - Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerse…
FDA Drug · Class III · 2025-12-24 · Somerset Therapeutics - Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC…
FDA Drug · Class III · 2025-01-08 · Somerset Therapeutics - Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 7006…
FDA Drug · Class II · 2024-05-29 · Somerset Therapeutics
All Somerset Therapeutics recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0398-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.