Tris Pharma Inc.
FDA Regulatory Profile
Tris Pharma Inc. has 8 FDA recalls, 16 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-1517-2019 · Class II · Jul 11, 2019
- Latest inspection
- Nov 21, 2025 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 8 | 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 | 16 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1517-2019 | Class II | Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to… | Jul 11, 2019 |
| D-0494-2019 | Class II | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free… | Jan 15, 2019 |
| D-0495-2019 | Class II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye… | Jan 15, 2019 |
| D-0493-2019 | Class II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye… | Jan 15, 2019 |
| D-0335-2019 | Class II | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free… | Nov 26, 2018 |
| D-0337-2019 | Class II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye… | Nov 26, 2018 |
| D-0336-2019 | Class II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL… | Nov 26, 2018 |
| D-1126-2017 | Class II | Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL… | Jun 15, 2017 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Nov 21, 2025 | Monmouth Junction, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004712471 |
| Mar 8, 2024 | Monmouth Junction, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004712471 |
| Jun 8, 2021 | Monmouth Junction, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004712471 |
| Jan 23, 2019 | Monmouth Junction, NJ | Drugs | Official Action Indicated (OAI) | 3004712471 |
| Jan 23, 2019 | Cranbury, NJ | Drugs | No Action Indicated (NAI) | 3008079002 |
| Apr 16, 2018 | Monmouth Junction, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004712471 |
| Mar 20, 2017 | Monmouth Junction, NJ | Drugs | Official Action Indicated (OAI) | 3004712471 |
| Jan 27, 2016 | Monmouth Junction, NJ | Drugs | No Action Indicated (NAI) | 3004712471 |
| Aug 12, 2015 | Monmouth Junction, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004712471 |
| Oct 1, 2014 | Monmouth Junction, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004712471 |
| Jan 21, 2014 | Monmouth Junction, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004712471 |
| Jan 21, 2014 | Cranbury, NJ | Drugs | No Action Indicated (NAI) | 3008079002 |
| Jun 15, 2012 | Monmouth Junction, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004712471 |
| May 6, 2011 | Monmouth Junction, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004712471 |
| Apr 30, 2010 | Monmouth Junction, NJ | Drugs | No Action Indicated (NAI) | 3004712471 |
| Nov 3, 2009 | Monmouth Junction, NJ | Drugs | No Action Indicated (NAI) | 3004712471 |
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.