Azurity Pharmaceuticals, Inc.
Azurity Pharmaceuticals, Inc. has 4 FDA recalls (2 Class I), 8 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0323-2024 · Class I · Jan 4, 2024
- Latest inspection
- Dec 12, 2025 · NAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 4 (2 Class I) | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 8 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 1 | 1 | 1 |
| 2023 | 1 | 0 | 0 | 2 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 1 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0323-2024 | Class I | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for… | Jan 4, 2024 |
| D-0213-2024 | Class III | Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity… | Dec 8, 2023 |
| D-0489-2023 | Class II | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials… | Feb 15, 2023 |
| D-0003-2022 | Class I | Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1… | Aug 24, 2021 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 12, 2025 | Woburn, MA | Drugs | No Action Indicated (NAI) | 3003395329 |
| Nov 14, 2024 | Atlanta, GA | Drugs | No Action Indicated (NAI) | 3029797518 |
| Mar 2, 2023 | Wilmington, MA | Drugs | No Action Indicated (NAI) | 3021346595 |
| Feb 24, 2022 | Woburn, MA | Drugs | Voluntary Action Indicated (VAI) | 3003395329 |
| Jul 26, 2019 | Woburn, MA | Drugs | No Action Indicated (NAI) | 3003395329 |
| Apr 19, 2016 | Woburn, MA | Drugs | No Action Indicated (NAI) | 3003395329 |
| Jan 29, 2014 | Woburn, MA | Drugs | Voluntary Action Indicated (VAI) | 3003395329 |
| Mar 19, 2010 | Woburn, MA | Drugs | No Action Indicated (NAI) | 3003395329 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Azurity Pharmaceuticals, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003395329 | Woburn, MA | 6 | Dec 12, 2025 |
| FEI 3029797518 | Atlanta, GA | 1 | Nov 14, 2024 |
| FEI 3021346595 | Wilmington, MA | 1 | Mar 2, 2023 |
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