Dexamethasone Sodium Phosphate Injection recall
FDA recall D-0398-2026 · initiated Feb 4, 2026
SOMERSET THERAPEUTICS LLC recalled Dexamethasone Sodium Phosphate Injection in Feb 2026 — an FDA Class II recall (D-0398-2026) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 62190 vials
Details
- 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
- Recalling company
- Somerset Therapeutics, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Feb 4, 2026
- FDA report date
- Mar 25, 2026
Frequently asked
- Was Dexamethasone Sodium Phosphate Injection recalled?
- SOMERSET THERAPEUTICS LLC recalled Dexamethasone Sodium Phosphate Injection in Feb 2026 — an FDA Class II recall (D-0398-2026) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Dexamethasone Sodium Phosphate Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0398-2026 was: 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.
- Is a recalled Dexamethasone Sodium Phosphate Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Dexamethasone Sodium Phosphate Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: A240421, Exp 07/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0398-2026.