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Class II · ModerateActive recall

Dexamethasone Sodium Phosphate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: A240421, Exp 07/31/2026
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySomerset Therapeutics, LLC
Brand nameDEXAMETHASONE SODIUM PHOSPHATE
Generic nameDEXAMETHASONE SODIUM PHOSPHATE
Active ingredient(s)DEXAMETHASONE SODIUM PHOSPHATE
Distributed by / forSomerset Therapeutics, LLC., Somerset, NJ 08873
Show the full FDA record
Full product labelDexamethasone 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 firmSOMERSET THERAPEUTICS LLC
DistributionNationwide in the USA
Quantity62190 vials
Recall initiated2026-02-04
Report date2026-03-25
Recall completed—
Recall numberD-0398-2026
ClassificationClass II
FDA statusOngoing
Origin on fileSomerset NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.