Somerset Therapeutics recalls
Somerset Therapeutics appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2026-03-25.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 9 |
|---|---|
| Published | 2020-07-15 to 2026-03-25 |
| By agency | FDA Drug (9) |
| By classification | Class III (7), Class II (2) |
| By status | ongoing (5), terminated (4) |
| Distribution named in notices | US |
Recalls
- Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset…
FDA Drug · Class II · 2026-03-25 · Somerset Therapeutics
Reason: 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 imp… - Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset The…
FDA Drug · Class III · 2025-12-24 · Somerset Therapeutics
Reason: Subpotent product:out of specification assay results observed during long term stability testing. - Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Th…
FDA Drug · Class III · 2025-12-24 · Somerset Therapeutics
Reason: Subpotent product:out of specification assay results observed during long term stability testing. - Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerse…
FDA Drug · Class III · 2025-12-24 · Somerset Therapeutics
Reason: Subpotent product:out of specification assay results observed during long term stability testing. - Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC…
FDA Drug · Class III · 2025-01-08 · Somerset Therapeutics
Reason: Failed Impurities/Degradation Specifications - 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 7006…
FDA Drug · Class II · 2024-05-29 · Somerset Therapeutics
Reason: Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI). - Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024
FDA Drug · Class III · 2020-07-15 · Somerset Therapeutics
Reason: 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. - Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024
FDA Drug · Class III · 2020-07-15 · Somerset Therapeutics
Reason: 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. - Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024
FDA Drug · Class III · 2020-07-15 · Somerset Therapeutics
Reason: 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.