Amphastar Pharmaceuticals, Inc. FDA Record
Amphastar Pharmaceuticals, Inc. has 1 FDA recall, 14 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Amphastar Pharmaceuticals, Inc." is on file.
- Latest recall
- D-1124-2017 · Class II · Aug 15, 2017
- Latest inspection
- Nov 7, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 14 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | 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 | 2 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 3 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 1 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-1124-2017 | Class II | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only… | Aug 15, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 7, 2025 | Rancho Cucamonga, CA | Drugs | Voluntary Action Indicated (VAI) | 3002936358 |
| Apr 3, 2025 | Rancho Cucamonga, CA | Drugs | No Action Indicated (NAI) | 3002936358 |
| Mar 1, 2024 | Rancho Cucamonga, CA | Drugs | Voluntary Action Indicated (VAI) | 3002936358 |
| Jun 22, 2021 | Rancho Cucamonga, CA | Drugs | No Action Indicated (NAI) | 3002936358 |
| Nov 22, 2019 | Rancho Cucamonga, CA | Drugs | No Action Indicated (NAI) | 3002936358 |
| Nov 21, 2019 | Rancho Cucamonga, CA | Drugs | No Action Indicated (NAI) | 3002936358 |
| Jul 25, 2019 | Rancho Cucamonga, CA | Drugs | No Action Indicated (NAI) | 3002936358 |
| Mar 31, 2017 | Rancho Cucamonga, CA | Drugs | Voluntary Action Indicated (VAI) | 3002936358 |
| Aug 8, 2014 | Rancho Cucamonga, CA | Drugs | Voluntary Action Indicated (VAI) | 3002936358 |
| Mar 3, 2014 | Rancho Cucamonga, CA | Drugs | No Action Indicated (NAI) | 3002936358 |
| Feb 6, 2013 | Rancho Cucamonga, CA | Drugs | Voluntary Action Indicated (VAI) | 3002936358 |
| Jun 28, 2012 | Rancho Cucamonga, CA | Drugs | Voluntary Action Indicated (VAI) | 3002936358 |
| May 6, 2011 | Rancho Cucamonga, CA | Drugs | No Action Indicated (NAI) | 3002936358 |
| Aug 19, 2009 | Rancho Cucamonga, CA | Drugs | Voluntary Action Indicated (VAI) | 3002936358 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002936358 | Rancho Cucamonga, CA | 14 | Nov 7, 2025 |
Amphastar Pharmaceuticals, Inc. and the FDA: common questions
Has Amphastar Pharmaceuticals, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Amphastar Pharmaceuticals, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Amphastar Pharmaceuticals, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Amphastar Pharmaceuticals, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Amphastar Pharmaceuticals, Inc.?
The most recent FDA inspection on file ended Nov 7, 2025 at Rancho Cucamonga, CA and was classified VAI. FDA has 14 inspections of Amphastar Pharmaceuticals, Inc. on file.
Has Amphastar Pharmaceuticals, Inc. had an FDA recall?
Yes. Amphastar Pharmaceuticals, Inc. has 1 FDA recall on record. The most recent started Aug 15, 2017.
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