McKesson FDA Recalls

3 recalls on file across drugs, 1 of them Class I and 3 still open. Matched by name to MCK.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, ManClass IIJun 10, 2026Temperature Abuse: Product was stored incorrectly in a contr	Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a re	Class IIDrugs	Jun 10, 2026
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPhaClass IJan 16, 2026Temperature Abuse. 116 cartons with specific serial numbers	Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a contr	Class IDrugs	Jan 16, 2026
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRIClass IIJan 17, 2025cGMP Deviations: Product intended for quarantine was inadver	cGMP Deviations: Product intended for quarantine was inadvertently distributed.	Class IIDrugs	Jan 17, 2025