Reported Mar 25, 2026 · Ongoing
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only,…
Somerset Therapeutics LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SOMERSET THERAPEUTICS LLC · 300 Franklin Square Dr · Somerset, NJ · 08873-4187
Is this the product you have?
- Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only
- Manufactured forSomerset Therapeutics, LLC., Somerset, NJ 08873
- NDC carton70069-025-10
- NDC vial70069-025-01
- Lot codes and dates
Lot #: A240421Exp 07/31/2026
- Amount recalled
- 62190 vials
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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