Purdue Pharma, LP FDA Record
Purdue Pharma, LP has 3 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Purdue Pharma, LP" is on file.
- Latest recall
- D-0070-2018 · Class II · Oct 5, 2017
- Latest inspection
- Apr 26, 2019 · VAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 3 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 1 | 0 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0070-2018 | Class II | Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford… | Oct 5, 2017 |
| D-0810-2016 | Class III | Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by… | Mar 31, 2016 |
| D-1278-2015 | Class III | Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton… | Jul 13, 2015 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 26, 2019 | Pickering, Canada | Drugs | Voluntary Action Indicated (VAI) | 3003287869 |
| Aug 4, 2017 | Pickering, Canada | Drugs | No Action Indicated (NAI) | 3003287869 |
| Jul 10, 2015 | Pickering, Canada | Drugs | Voluntary Action Indicated (VAI) | 3003287869 |
| Nov 6, 2014 | Cranbury, NJ | Drugs | No Action Indicated (NAI) | 3004561576 |
| Sep 13, 2013 | Pickering, Canada | Drugs | Voluntary Action Indicated (VAI) | 3003287869 |
| Jul 15, 2011 | Pickering, Canada | Drugs | Voluntary Action Indicated (VAI) | 3003287869 |
- 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 3003287869 | Pickering, Canada | 5 | Apr 26, 2019 |
| FEI 3004561576 | Cranbury, NJ | 1 | Nov 6, 2014 |
Purdue Pharma, LP and the FDA: common questions
Has Purdue Pharma, LP received an FDA warning letter?
No FDA warning letter addressed to the name "Purdue Pharma, LP" 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 Purdue Pharma, LP received an FDA Form 483?
FDA has not published a Form 483 for "Purdue Pharma, LP" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Purdue Pharma, LP?
The most recent FDA inspection on file ended Apr 26, 2019 at Pickering, Canada and was classified VAI. FDA has 6 inspections of Purdue Pharma, LP on file.
Has Purdue Pharma, LP had an FDA recall?
Yes. Purdue Pharma, LP has 3 FDA recalls on record. The most recent started Oct 5, 2017.
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