Class II · Moderate risk
Dexamethasone Moxifloxacin Ketorolac
Presence of particulate matter - Glass like particles.
Dexamethasone Sodium Phosphate Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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
Affected NDCs
70069-0025-01
70069-0025-10
Compare with the code on your package — it is the most precise check available.
Drug: Dexamethasone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Dexamethasone Sodium Phosphate NDC 70069-0025 |
10 mg/mL | Injection, Solution Intramuscular|intravenous |
Somerset Therapeutics, LLC | Rx |
- Recalling firm
- Somerset Therapeutics LLC
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0398-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Dexamethasone recalls
See all
Class II · Moderate risk
Dexamethasone Moxifloxacin
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Temperature Abuse
Class II · Moderate risk
Dexonto 0.4%
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Class II · Moderate risk
Dexamethasone Sodium Phosphate injection USP
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Other recalls by Somerset Therapeutics LLC
All 2026 recalls
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications
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