McKesson Medical-Surgical Inc. FDA Record
McKesson Medical-Surgical Inc. has 1 FDA recall, 30 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "McKesson Medical-Surgical Inc." is on file.
- Latest recall
- D-0668-2017 · Class II · Mar 8, 2017
- Latest inspection
- Oct 21, 2026 · NAI
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 | 30 | 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 | 4 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 3 | 0 | 0 | 0 | 0 |
| 2023 | 3 | 0 | 0 | 0 | 0 |
| 2022 | 4 | 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 | 3 | 0 | 0 | 1 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0668-2017 | Class II | hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per… | Mar 8, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 21, 2026 | Northborough, MA | Food/Cosmetics | No Action Indicated (NAI) | 3004953226 |
| Jun 2, 2026 | Bethlehem, PA | Food/Cosmetics | No Action Indicated (NAI) | 3015878938 |
| Mar 24, 2026 | Orlando, FL | Food/Cosmetics | No Action Indicated (NAI) | 3004665444 |
| Jan 22, 2026 | Roseville, CA | Food/Cosmetics | No Action Indicated (NAI) | 3014511004 |
| Dec 6, 2024 | Kansas City, MO | Food/Cosmetics | No Action Indicated (NAI) | 3004672131 |
| May 29, 2024 | Chino, CA | Food/Cosmetics | No Action Indicated (NAI) | 3010042530 |
| May 3, 2024 | Suwanee, GA | Food/Cosmetics | No Action Indicated (NAI) | 3011141703 |
| Aug 15, 2023 | Rock Hill, SC | Food/Cosmetics | No Action Indicated (NAI) | 3011747001 |
| Jul 25, 2023 | Rochester, NY | Food/Cosmetics | No Action Indicated (NAI) | 3005251507 |
| Mar 20, 2023 | Houston, TX | Food/Cosmetics | No Action Indicated (NAI) | 3005251423 |
| Sep 30, 2022 | Auburn, WA | Food/Cosmetics | No Action Indicated (NAI) | 3005247588 |
| Sep 20, 2022 | Rogers, MN | Food/Cosmetics | No Action Indicated (NAI) | 3011746987 |
| Sep 15, 2022 | Kent, WA | Food/Cosmetics | No Action Indicated (NAI) | 3031225714 |
| Sep 14, 2022 | Grapevine, TX | Food/Cosmetics | No Action Indicated (NAI) | 3004807513 |
| Jul 11, 2019 | Orlando, FL | Food/Cosmetics | No Action Indicated (NAI) | 3004665444 |
| Sep 14, 2017 | Glendale Heights, IL | Food/Cosmetics | No Action Indicated (NAI) | 1000143460 |
| Jun 6, 2017 | Suwanee, GA | Food/Cosmetics | No Action Indicated (NAI) | 3011141703 |
| Apr 3, 2017 | Northborough, MA | Food/Cosmetics | No Action Indicated (NAI) | 3004953226 |
| Dec 13, 2016 | Denver, CO | Food/Cosmetics | No Action Indicated (NAI) | 3004680511 |
| Nov 17, 2016 | Little Rock, AR | Food/Cosmetics | No Action Indicated (NAI) | 3004790106 |
- 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 3004953226 | Northborough, MA | 2 | Oct 21, 2026 |
| FEI 3015878938 | Bethlehem, PA | 1 | Jun 2, 2026 |
| FEI 3004665444 | Orlando, FL | 3 | Mar 24, 2026 |
| FEI 3014511004 | Roseville, CA | 1 | Jan 22, 2026 |
| FEI 3004672131 | Kansas City, MO | 4 | Dec 6, 2024 |
| FEI 3010042530 | Chino, CA | 1 | May 29, 2024 |
| FEI 3011141703 | Suwanee, GA | 2 | May 3, 2024 |
| FEI 3011747001 | Rock Hill, SC | 1 | Aug 15, 2023 |
| FEI 3005251507 | Rochester, NY | 1 | Jul 25, 2023 |
| FEI 3005251423 | Houston, TX | 1 | Mar 20, 2023 |
| FEI 3005247588 | Auburn, WA | 1 | Sep 30, 2022 |
| FEI 3011746987 | Rogers, MN | 1 | Sep 20, 2022 |
| FEI 3031225714 | Kent, WA | 3 | Sep 15, 2022 |
| FEI 3004807513 | Grapevine, TX | 3 | Sep 14, 2022 |
| FEI 1000143460 | Glendale Heights, IL | 1 | Sep 14, 2017 |
| FEI 3004680511 | Denver, CO | 1 | Dec 13, 2016 |
| FEI 3004790106 | Little Rock, AR | 1 | Nov 17, 2016 |
| FEI 3004670186 | Tolleson, AZ | 1 | Jun 8, 2016 |
| FEI 3008069756 | Swedesboro, NJ | 1 | Dec 8, 2011 |
McKesson Medical-Surgical Inc. and the FDA: common questions
Has McKesson Medical-Surgical Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "McKesson Medical-Surgical 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 McKesson Medical-Surgical Inc. received an FDA Form 483?
FDA has not published a Form 483 for "McKesson Medical-Surgical Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect McKesson Medical-Surgical Inc.?
The most recent FDA inspection on file ended Oct 21, 2026 at Northborough, MA and was classified NAI. FDA has 30 inspections of McKesson Medical-Surgical Inc. on file.
Has McKesson Medical-Surgical Inc. had an FDA recall?
Yes. McKesson Medical-Surgical Inc. has 1 FDA recall on record. The most recent started Mar 8, 2017.
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