Home / Brands / SOMERSET THERAPEUTICS
SOMERSET THERAPEUTICS Recalls
9 recalls on record · July 15, 2020 to March 25, 2026 · Drugs
Recalls by year
20
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 25, 2026DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufac
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.
December 24, 2025DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufa
Hazard: Subpotent product:out of specification assay results observed during long term stability testing.
December 24, 2025DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactur
Hazard: Subpotent product:out of specification assay results observed during long term stability testing.
December 24, 2025DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufacture
Hazard: Subpotent product:out of specification assay results observed during long term stability testing.
January 8, 2025DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somer
Hazard: Failed Impurities/Degradation Specifications
May 29, 2024DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-D
Hazard: Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
July 15, 2020DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollyw
Hazard: Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
July 15, 2020DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollyw
Hazard: Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
July 15, 2020DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywo
Hazard: Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.