Mckesson Drug Company
FDA Regulatory Profile
Mckesson Drug Company has 12 FDA recalls (1 Class I), 56 inspections, 5 510(k) clearances and 2 compliance actions on record.
- Latest recall
- D-0714-2026 · Class II · Jun 10, 2026
- Latest inspection
- Oct 28, 2025 · NAI
- Latest 510(k)
- Aug 2, 1977
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 12 (1 Class I) | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 5 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 56 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 2 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0714-2026 | Class II | Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous… | Jun 10, 2026 |
| D-0353-2026 | Class I | UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only… | Jan 16, 2026 |
| D-0213-2025 | Class II | Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx… | Jan 17, 2025 |
| D-0347-2024 | Class II | CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for… | Feb 12, 2024 |
| D-0851-2022 | Class II | Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc… | Apr 21, 2022 |
| D-0849-2022 | Class II | Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson… | Apr 21, 2022 |
| D-0847-2022 | Class II | Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent… | Apr 21, 2022 |
| D-0850-2022 | Class II | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15… | Apr 21, 2022 |
| D-0848-2022 | Class II | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by… | Apr 21, 2022 |
| D-0630-2021 | Class III | Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson… | May 26, 2021 |
| D-1172-2018 | Class II | Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx… | Aug 14, 2018 |
| D-0005-2015 | Class II | Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured… | Sep 12, 2014 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Oct 28, 2025 | Aurora, CO | Food/Cosmetics | No Action Indicated (NAI) | 3004386754 |
| Sep 10, 2025 | Tolleson, AZ | Food/Cosmetics | No Action Indicated (NAI) | 2013605 |
| Aug 6, 2025 | Ruther Glen, VA | Food/Cosmetics | No Action Indicated (NAI) | 3009149966 |
| Jun 26, 2025 | Montgomery, NY | Food/Cosmetics | No Action Indicated (NAI) | 3013914890 |
| Jun 12, 2025 | Duluth, GA | Food/Cosmetics | No Action Indicated (NAI) | 1030548 |
| Jul 9, 2024 | Santa Fe Springs, CA | Food/Cosmetics | No Action Indicated (NAI) | 2015316 |
| Jul 9, 2024 | Robbinsville, NJ | Food/Cosmetics | No Action Indicated (NAI) | 3011067991 |
| Feb 27, 2024 | Irving, TX | Drugs | No Action Indicated (NAI) | 3013391744 |
| Aug 24, 2023 | Anchorage, AK | Food/Cosmetics | No Action Indicated (NAI) | 3004399761 |
| Jul 6, 2023 | Clear Lake, IA | Food/Cosmetics | No Action Indicated (NAI) | 3012116944 |
| Mar 23, 2023 | Conroe, TX | Food/Cosmetics | No Action Indicated (NAI) | 3006492894 |
| Jan 30, 2023 | Mc Calla, AL | Food/Cosmetics | No Action Indicated (NAI) | 3005147053 |
| Jan 5, 2023 | Wilsonville, OR | Food/Cosmetics | No Action Indicated (NAI) | 3011865 |
| Sep 1, 2022 | Oklahoma City, OK | Food/Cosmetics | No Action Indicated (NAI) | 1000138475 |
| Jun 21, 2022 | Olive Branch, MS | Food/Cosmetics | No Action Indicated (NAI) | 3009463154 |
| Jun 17, 2022 | Washington Court House, OH | Food/Cosmetics | No Action Indicated (NAI) | 3001734061 |
| Aug 19, 2021 | Aurora, CO | Food/Cosmetics | No Action Indicated (NAI) | 1711623 |
| Jul 12, 2021 | Duluth, GA | Food/Cosmetics | No Action Indicated (NAI) | 1030548 |
| Jun 24, 2021 | Puyallup, WA | Food/Cosmetics | No Action Indicated (NAI) | 3015493024 |
| Mar 15, 2021 | Salt Lake City, UT | Food/Cosmetics | No Action Indicated (NAI) | 1000138446 |
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 3004386754 | Aurora, CO | 1 | Oct 28, 2025 |
| FEI 2013605 | Tolleson, AZ | 3 | Sep 10, 2025 |
| FEI 3009149966 | Ruther Glen, VA | 2 | Aug 6, 2025 |
| FEI 3013914890 | Montgomery, NY | 1 | Jun 26, 2025 |
| FEI 1030548 | Duluth, GA | 4 | Jun 12, 2025 |
| FEI 2015316 | Santa Fe Springs, CA | 3 | Jul 9, 2024 |
| FEI 3011067991 | Robbinsville, NJ | 1 | Jul 9, 2024 |
| FEI 3013391744 | Irving, TX | 1 | Feb 27, 2024 |
| FEI 3004399761 | Anchorage, AK | 2 | Aug 24, 2023 |
| FEI 3012116944 | Clear Lake, IA | 1 | Jul 6, 2023 |
| FEI 3006492894 | Conroe, TX | 1 | Mar 23, 2023 |
| FEI 3005147053 | Mc Calla, AL | 2 | Jan 30, 2023 |
| FEI 3011865 | Wilsonville, OR | 2 | Jan 5, 2023 |
| FEI 1000138475 | Oklahoma City, OK | 3 | Sep 1, 2022 |
| FEI 3009463154 | Olive Branch, MS | 1 | Jun 21, 2022 |
| FEI 3001734061 | Washington Court House, OH | 2 | Jun 17, 2022 |
| FEI 1711623 | Aurora, CO | 2 | Aug 19, 2021 |
| FEI 3015493024 | Puyallup, WA | 1 | Jun 24, 2021 |
| FEI 1000138446 | Salt Lake City, UT | 1 | Mar 15, 2021 |
| FEI 3004386312 | Methuen, MA | 3 | Sep 23, 2020 |
| FEI 3009131128 | Honolulu, HI | 1 | Jan 16, 2020 |
| FEI 3004390400 | Buffalo, NY | 3 | Oct 31, 2018 |
| FEI 1940861 | O Fallon, MO | 2 | Aug 2, 2018 |
| FEI 1020277 | Memphis, TN | 2 | Jun 8, 2018 |
| FEI 3002574153 | Memphis, TN | 3 | Mar 22, 2018 |
| FEI 3004403942 | Delran, NJ | 2 | Dec 13, 2017 |
| FEI 3004668525 | Livonia, MI | 3 | Nov 28, 2017 |
| FEI 3019194 | Everett, WA | 2 | Sep 11, 2017 |
| FEI 3015245770 | Alpharetta, GA | 1 | Apr 29, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K771175 | RESUSCITATOR, MS30 | Aug 2, 1977 |
| K761196 | NITROUS OXIDE SCAVENGING MASK | Dec 13, 1976 |
| K761194 | HLR QUICK-FIT HEART-LUNG RESUSCITATOR | Dec 9, 1976 |
| K761195 | ESOPHAGEAL OBTURATION AIRWAY | Dec 9, 1976 |
| K760017 | CONSIOUS SEDATION (ANALOR P-76) | Jul 20, 1976 |