AstraZeneca Pharmaceuticals LP
FDA Regulatory Profile
AstraZeneca Pharmaceuticals LP has 6 FDA recalls (1 Class I), 64 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0028-2026 · Class II · Oct 8, 2025
- Latest inspection
- Jun 26, 2026 · 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 | 6 (1 Class I) | 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 | 64 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|
Astrazeneca
Same company group | 2 | 0 | 32 | 0 | Jan 11, 2013 (D-199-2013) |
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0028-2026 | Class II | Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only… | Oct 8, 2025 |
| D-0585-2018 | Class III | Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca… | Feb 23, 2018 |
| D-0958-2017 | Class I | BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for… | May 25, 2017 |
| D-0781-2016 | Class II | Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses… | Feb 5, 2016 |
| D-1141-2015 | Class II | NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only… | Jun 10, 2015 |
| D-840-2013 | Class II | MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for… | Jun 21, 2013 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jun 26, 2026 | Newark, DE | Drugs | Voluntary Action Indicated (VAI) | 2517100 |
| Apr 3, 2026 | Coppell, TX | Drugs | No Action Indicated (NAI) | 3010199915 |
| Jan 14, 2026 | Gaithersburg, MD | Drugs | No Action Indicated (NAI) | 1000198729 |
| Jun 24, 2025 | Philadelphia, PA | Biologics | No Action Indicated (NAI) | 3004829714 |
| Oct 25, 2024 | Gaithersburg, MD | Drugs | No Action Indicated (NAI) | 1000198729 |
| Oct 4, 2024 | Wilmington, DE | Drugs | No Action Indicated (NAI) | 2518137 |
| May 31, 2024 | Gaithersburg, MD | Drugs | Voluntary Action Indicated (VAI) | 1000198729 |
| Jan 22, 2024 | Gaithersburg, MD | Drugs | No Action Indicated (NAI) | 1000198729 |
| Sep 20, 2023 | Wilmington, DE | Drugs | No Action Indicated (NAI) | 2518137 |
| Sep 19, 2023 | Mount Vernon, IN | Drugs | Voluntary Action Indicated (VAI) | 1825662 |
| Jul 19, 2023 | Newark, DE | Drugs | No Action Indicated (NAI) | 2517100 |
| Jul 18, 2023 | Gaithersburg, MD | Drugs | No Action Indicated (NAI) | 1000198729 |
| Jan 19, 2023 | Frederick, MD | Drugs | Voluntary Action Indicated (VAI) | 3002617771 |
| Jul 22, 2022 | Philadelphia, PA | Biologics | Voluntary Action Indicated (VAI) | 3004829714 |
| Oct 25, 2021 | Redwood City, CA | Drugs | No Action Indicated (NAI) | 3011389428 |
| Sep 30, 2021 | Gaithersburg, MD | Drugs | No Action Indicated (NAI) | 1000198729 |
| Feb 26, 2021 | Gaithersburg, MD | Drugs | No Action Indicated (NAI) | 1000198729 |
| Oct 27, 2020 | Gaithersburg, MD | Drugs | No Action Indicated (NAI) | 1000198729 |
| Oct 11, 2018 | Gaithersburg, MD | Drugs | No Action Indicated (NAI) | 1000198729 |
| Aug 17, 2018 | Frederick, MD | Drugs | Voluntary Action Indicated (VAI) | 3002617771 |
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 2517100 | Newark, DE | 7 | Jun 26, 2026 |
| FEI 3010199915 | Coppell, TX | 5 | Apr 3, 2026 |
| FEI 1000198729 | Gaithersburg, MD | 15 | Jan 14, 2026 |
| FEI 3004829714 | Philadelphia, PA | 9 | Jun 24, 2025 |
| FEI 2518137 | Wilmington, DE | 12 | Oct 4, 2024 |
| FEI 1825662 | Mount Vernon, IN | 8 | Sep 19, 2023 |
| FEI 3002617771 | Frederick, MD | 5 | Jan 19, 2023 |
| FEI 3011389428 | Redwood City, CA | 2 | Oct 25, 2021 |
| FEI 3011604962 | Denver, CO | 1 | Mar 10, 2016 |