CLASS II ONGOING Drug recall · Reported 25 Mar 2026 · FDA Enforcement Report
Dexamethasone Sodium Phosphate Injection, USP, 100 mg recalled
Somerset Therapeutics is recalling Dexamethasone Sodium Phosphate Injection, USP, 100 mg/, (10 mg/mL), mL Multiple Dose Vials, distributed nationwide in the US. The recall was initiated on 4 Feb 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0398-2026
- FDA event ID
- 98388
- Recalling firm
- Somerset Therapeutics, Somerset, NJ
- Manufacturer
- Somerset Therapeutics, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Feb 2026
- FDA classified
- 18 Mar 2026
- Reported
- 25 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Feb 2026 | Recall initiated by company | |
| 18 Mar 2026 | Classified by FDA | +42 days |
| 25 Mar 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Dexamethasone Sodium Phosphate Injection, USP, 100 mg/, (10 mg/mL), mL Multiple Dose Vials recalled?
Yes. Somerset Therapeutics recalled Dexamethasone Sodium Phosphate Injection, USP, 100 mg/, (10 mg/mL), mL Multiple Dose Vials on 4 Feb 2026. The recall is Class II and its status is Ongoing. Recall number D-0398-2026.
Why was it 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.
Which lots are affected?
Lot #: A240421, Exp 07/31/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Somerset Therapeutics
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 10 mg/* (2mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Foreign Material | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 200mg/*(10mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Foreign Material | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 20 mg/*,(2 mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Foreign Material | Nationwide |
| Drug | CLASS III | Atropine Sulfate Ophthalmic Solution recalled by Somerset TherapeuticsAtropine Sulfate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Haloperidol decanoate Injection 50mg/mL recalledHaloperidol Decanoate | Somerset Therapeutics | Foreign Material | Nationwide |
Other Dexamethasone Sodium Phosphate recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Sodium Phosphate injection USP, 120mg recalled by Eugia USDexamethasone Sodium Phosphate | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS III | Dexamethasone Sodium Phosphate Injection, USP, 20 mg recalledDexamethasone Sodium Phosphate | West-Ward Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL Vials recalledDexamethasone Sodium Phosphate | West-Ward Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Dexamethasone Sodium Phosphate Injection, all strengths recalled | FVS Holdings | Sterility | Nationwide |