SOMERSET THERAPEUTICS LLC Recalls
6 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Drug Recalls (6)
- Class II
February 4, 2026
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: 70069-02
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.
- Class III
November 26, 2025
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL
Subpotent product:out of specification assay results observed during long term stability testing.
- Class III
November 26, 2025
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single d
Subpotent product:out of specification assay results observed during long term stability testing.
- Class III
November 26, 2025
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-do
Subpotent product:out of specification assay results observed during long term stability testing.
- Class III
December 16, 2024
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
Failed Impurities/Degradation Specifications
- Class II
April 24, 2024
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics,
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.