Bausch Health Companies, Inc. FDA Record
Bausch Health Companies, Inc. has 6 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bausch Health Companies, Inc." is on file.
- Latest recall
- D-0355-2024 · Class II · Feb 2, 2024
- Latest inspection
- Jan 19, 2024 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 6 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 15 | 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 | 1 | 0 | 0 | 1 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 4 | 0 |
| 2020 | 0 | 0 | 0 | 1 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0355-2024 | Class II | Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of… | Feb 2, 2024 |
| D-0639-2021 | Class III | Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a… | Jun 8, 2021 |
| D-0638-2021 | Class III | Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant… | Jun 8, 2021 |
| D-0244-2021 | Class III | Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a… | Jan 7, 2021 |
| D-0243-2021 | Class III | Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant… | Jan 7, 2021 |
| D-0054-2021 | Class II | Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside… | Jul 13, 2020 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 19, 2024 | Laval, Canada | Drugs | No Action Indicated (NAI) | 3002807186 |
| May 19, 2023 | Steinbach, Canada | Drugs | No Action Indicated (NAI) | 3002806613 |
| Sep 29, 2022 | Laval, Canada | Drugs | No Action Indicated (NAI) | 3002807186 |
| Sep 19, 2019 | Laval, Canada | Drugs | No Action Indicated (NAI) | 3002807186 |
| May 18, 2018 | Steinbach, Canada | Drugs | No Action Indicated (NAI) | 3002806613 |
| Feb 17, 2017 | Laval, Canada | Drugs | No Action Indicated (NAI) | 3002807186 |
| Sep 9, 2016 | Steinbach, Canada | Drugs | No Action Indicated (NAI) | 3002806613 |
| Feb 20, 2015 | Laval, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807186 |
| Jun 17, 2014 | Laval, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807186 |
| May 30, 2014 | Steinbach, Canada | Drugs | No Action Indicated (NAI) | 3002806613 |
| Sep 20, 2013 | Laval, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807186 |
| Mar 1, 2012 | Steinbach, Canada | Drugs | No Action Indicated (NAI) | 3002806613 |
| Jul 28, 2011 | Laval, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807186 |
| Aug 7, 2009 | Steinbach, Canada | Drugs | No Action Indicated (NAI) | 3002806613 |
| Oct 30, 2008 | Laval, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807186 |
- 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 3002807186 | Laval, Canada | 9 | Jan 19, 2024 |
| FEI 3002806613 | Steinbach, Canada | 6 | May 19, 2023 |
Bausch Health Companies, Inc. and the FDA: common questions
Has Bausch Health Companies, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Bausch Health Companies, 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 Bausch Health Companies, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Bausch Health Companies, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bausch Health Companies, Inc.?
The most recent FDA inspection on file ended Jan 19, 2024 at Laval, Canada and was classified NAI. FDA has 15 inspections of Bausch Health Companies, Inc. on file.
Has Bausch Health Companies, Inc. had an FDA recall?
Yes. Bausch Health Companies, Inc. has 6 FDA recalls on record. The most recent started Feb 2, 2024.
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