⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

SOMERSET THERAPEUTICS LLC: Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset

DrugsSource: FDA (drug) · Date: 2026-03-25

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
SOMERSET THERAPEUTICS LLC
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
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-02-04
Code info
Lot #: A240421, Exp 07/31/2026
Product quantity
62190 vials
Voluntary mandated
Voluntary: Firm initiated
City
Somerset
State
NJ
Country
United States
Event id
98388
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