Home / Recalls / SOMERSET THERAPEUTICS LLC / D-0398-2026

D-0398-2026 Class II Ongoing

Recalled by SOMERSET THERAPEUTICS LLC — Somerset, NJ

Recall Details

Product Type
Drugs
Report Date
March 25, 2026
Initiation Date
February 4, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
62190 vials

Product Description

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 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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: A240421, Exp 07/31/2026

Other recalls by SOMERSET THERAPEUTICS LLC

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  • D-0238-2026 Class III — Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multipl (November 26, 2025)
  • D-0237-2026 Class III — Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-do (November 26, 2025)
  • D-0169-2025 Class III — Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufacture (December 16, 2024)
  • D-0506-2024 Class II — Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials ( (April 24, 2024)
  • D-1374-2020 Class III — Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufacture (June 4, 2020)
  • D-1375-2020 Class III — Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufacture (June 4, 2020)
  • D-1373-2020 Class III — Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured (June 4, 2020)