Somerset Therapeutics Private Limited
FDA Regulatory Profile
Somerset Therapeutics Private Limited has 5 FDA recalls, 10 inspections, 0 510(k) clearances and 3 compliance actions on record.
- Latest recall
- D-0356-2025 · Class II · Mar 21, 2025
- Latest inspection
- Feb 21, 2025 · OAI
Newer recall under related name Somerset Therapeutics: Feb 4, 2026, D-0398-2026.
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 5 | 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 | 10 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 3 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|
Somerset Therapeutics
Same company group | 9 | 0 | 1 | 0 | Feb 4, 2026 (D-0398-2026) |
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0356-2025 | Class II | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset… | Mar 21, 2025 |
| D-0354-2025 | Class II | Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only… | Mar 21, 2025 |
| D-0357-2025 | Class II | Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset… | Mar 21, 2025 |
| D-0358-2025 | Class II | Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for… | Mar 21, 2025 |
| D-0355-2025 | Class II | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset… | Mar 21, 2025 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Feb 21, 2025 | Bengaluru, India | Drugs | Official Action Indicated (OAI) | 3003821988 |
| Oct 27, 2023 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3003821988 |
| Apr 4, 2022 | Bengaluru, India | Drugs | Official Action Indicated (OAI) | 3003821988 |
| Feb 19, 2020 | Bengaluru, India | Drugs | Official Action Indicated (OAI) | 3003821988 |
| Jul 23, 2019 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3003821988 |
| Dec 5, 2017 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3003821988 |
| Apr 24, 2017 | Bengaluru, India | Drugs | No Action Indicated (NAI) | 3003821988 |
| Aug 20, 2013 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3003821988 |
| Sep 20, 2011 | Bengaluru, India | Drugs | Official Action Indicated (OAI) | 3003821988 |
| Mar 31, 2009 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3003821988 |
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 3003821988 | Bengaluru, India | 10 | Feb 21, 2025 |