D-0398-2026 Class II Ongoing
FDA drug recall D-0398-2026 was initiated by SOMERSET THERAPEUTICS LLC on Feb 4, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 62190 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 25, 2026
- Initiation Date
- Feb 4, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62190 vials
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: A240421, Exp 07/31/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0398-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026