Somerset Therapeutics recalls
FDA enforcement reports naming SOMERSET THERAPEUTICS LLC as the recalling firm.
- Recall reports
- 9
- Class I (serious)
- 0
- Most recent report
- Mar 25, 2026
- Mar 25, 2026Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Mult…Drug · SOMERSET THERAPEUTICS LLCFailed 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 imp…Class II
- Dec 24, 2025Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials…Drug · SOMERSET THERAPEUTICS LLCSubpotent product:out of specification assay results observed during long term stability testing.Class III
- Dec 24, 2025Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose…Drug · SOMERSET THERAPEUTICS LLCSubpotent product:out of specification assay results observed during long term stability testing.Class III
- Dec 24, 2025Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vial…Drug · SOMERSET THERAPEUTICS LLCSubpotent product:out of specification assay results observed during long term stability testing.Class III
- Jan 8, 2025Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for:…Drug · SOMERSET THERAPEUTICS LLCFailed Impurities/Degradation SpecificationsClass III
- May 29, 2024Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 700…Drug · SOMERSET THERAPEUTICS LLCPresence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).Class II
- Jul 15, 2020Brimonidine Tartrate Opthalmic Solution 0Drug · SOMERSET THERAPEUTICS LLCFailed 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.Class III
- Jul 15, 2020Brimonidine Tartrate Opthalmic Solution 0Drug · SOMERSET THERAPEUTICS LLCFailed 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.Class III
- Jul 15, 2020Brimonidine Tartrate Opthalmic Solution 0Drug · SOMERSET THERAPEUTICS LLCFailed 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.Class III