SOMERSET THERAPEUTICS LLC
FDA Regulatory Profile
SOMERSET THERAPEUTICS LLC has 9 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0398-2026 · Class II · Feb 4, 2026
- Latest inspection
- Feb 27, 2026 · NAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 9 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0398-2026 | Class II | Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose… | Feb 4, 2026 |
| D-0238-2026 | Class III | Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per… | Nov 26, 2025 |
| D-0236-2026 | Class III | Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton… | Nov 26, 2025 |
| D-0237-2026 | Class III | Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton… | Nov 26, 2025 |
| D-0169-2025 | Class III | Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset… | Dec 16, 2024 |
| D-0506-2024 | Class II | Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01)… | Apr 24, 2024 |
| D-1375-2020 | Class III | Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset… | Jun 4, 2020 |
| D-1374-2020 | Class III | Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset… | Jun 4, 2020 |
| D-1373-2020 | Class III | Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset… | Jun 4, 2020 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3013895162 | Somerset, NJ | 1 | Feb 27, 2026 |