Home / Companies / McKesson Corporation Dba McKesson Drug Company

McKesson Corporation Dba McKesson Drug Company

FDA Regulatory Profile

McKesson Corporation Dba 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

Reviewing McKesson Corporation Dba McKesson Drug Company as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check McKesson Corporation Dba McKesson Drug Company yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls12 (1 Class I)Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances5Nov 8, 2026File dated Nov 2, 2026Current
Inspections56Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0714-2026Class IIGemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous…Jun 10, 2026
D-0353-2026Class IUDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only…Jan 16, 2026
D-0213-2025Class IIInflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx…Jan 17, 2025
D-0347-2024Class IICABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for…Feb 12, 2024
D-0851-2022Class IIErythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc…Apr 21, 2022
D-0849-2022Class IILidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson…Apr 21, 2022
D-0847-2022Class IIHalobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent…Apr 21, 2022
D-0850-2022Class IIBetamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15…Apr 21, 2022
D-0848-2022Class IILidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by…Apr 21, 2022
D-0630-2021Class IIILevetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson…May 26, 2021
D-1172-2018Class IIMegestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx…Aug 14, 2018
D-0005-2015Class IIAmiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured…Sep 12, 2014

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 28, 2025Aurora, COFood/CosmeticsNo Action Indicated (NAI)3004386754
Sep 10, 2025Tolleson, AZFood/CosmeticsNo Action Indicated (NAI)2013605
Aug 6, 2025Ruther Glen, VAFood/CosmeticsNo Action Indicated (NAI)3009149966
Jun 26, 2025Montgomery, NYFood/CosmeticsNo Action Indicated (NAI)3013914890
Jun 12, 2025Duluth, GAFood/CosmeticsNo Action Indicated (NAI)1030548
Jul 9, 2024Santa Fe Springs, CAFood/CosmeticsNo Action Indicated (NAI)2015316
Jul 9, 2024Robbinsville, NJFood/CosmeticsNo Action Indicated (NAI)3011067991
Feb 27, 2024Irving, TXDrugsNo Action Indicated (NAI)3013391744
Aug 24, 2023Anchorage, AKFood/CosmeticsNo Action Indicated (NAI)3004399761
Jul 6, 2023Clear Lake, IAFood/CosmeticsNo Action Indicated (NAI)3012116944
Mar 23, 2023Conroe, TXFood/CosmeticsNo Action Indicated (NAI)3006492894
Jan 30, 2023Mc Calla, ALFood/CosmeticsNo Action Indicated (NAI)3005147053
Jan 5, 2023Wilsonville, ORFood/CosmeticsNo Action Indicated (NAI)3011865
Sep 1, 2022Oklahoma City, OKFood/CosmeticsNo Action Indicated (NAI)1000138475
Jun 21, 2022Olive Branch, MSFood/CosmeticsNo Action Indicated (NAI)3009463154
Jun 17, 2022Washington Court House, OHFood/CosmeticsNo Action Indicated (NAI)3001734061
Aug 19, 2021Aurora, COFood/CosmeticsNo Action Indicated (NAI)1711623
Jul 12, 2021Duluth, GAFood/CosmeticsNo Action Indicated (NAI)1030548
Jun 24, 2021Puyallup, WAFood/CosmeticsNo Action Indicated (NAI)3015493024
Mar 15, 2021Salt Lake City, UTFood/CosmeticsNo 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

FacilityLocationInspectionsLatest
FEI 3004386754Aurora, CO1Oct 28, 2025
FEI 2013605Tolleson, AZ3Sep 10, 2025
FEI 3009149966Ruther Glen, VA2Aug 6, 2025
FEI 3013914890Montgomery, NY1Jun 26, 2025
FEI 1030548Duluth, GA4Jun 12, 2025
FEI 2015316Santa Fe Springs, CA3Jul 9, 2024
FEI 3011067991Robbinsville, NJ1Jul 9, 2024
FEI 3013391744Irving, TX1Feb 27, 2024
FEI 3004399761Anchorage, AK2Aug 24, 2023
FEI 3012116944Clear Lake, IA1Jul 6, 2023
FEI 3006492894Conroe, TX1Mar 23, 2023
FEI 3005147053Mc Calla, AL2Jan 30, 2023
FEI 3011865Wilsonville, OR2Jan 5, 2023
FEI 1000138475Oklahoma City, OK3Sep 1, 2022
FEI 3009463154Olive Branch, MS1Jun 21, 2022
FEI 3001734061Washington Court House, OH2Jun 17, 2022
FEI 1711623Aurora, CO2Aug 19, 2021
FEI 3015493024Puyallup, WA1Jun 24, 2021
FEI 1000138446Salt Lake City, UT1Mar 15, 2021
FEI 3004386312Methuen, MA3Sep 23, 2020
FEI 3009131128Honolulu, HI1Jan 16, 2020
FEI 3004390400Buffalo, NY3Oct 31, 2018
FEI 1940861O Fallon, MO2Aug 2, 2018
FEI 1020277Memphis, TN2Jun 8, 2018
FEI 3002574153Memphis, TN3Mar 22, 2018
FEI 3004403942Delran, NJ2Dec 13, 2017
FEI 3004668525Livonia, MI3Nov 28, 2017
FEI 3019194Everett, WA2Sep 11, 2017
FEI 3015245770Alpharetta, GA1Apr 29, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K771175RESUSCITATOR, MS30Aug 2, 1977
K761196NITROUS OXIDE SCAVENGING MASKDec 13, 1976
K761194HLR QUICK-FIT HEART-LUNG RESUSCITATORDec 9, 1976
K761195ESOPHAGEAL OBTURATION AIRWAYDec 9, 1976
K760017CONSIOUS SEDATION (ANALOR P-76)Jul 20, 1976

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.