Class I — life-threateningOngoing118 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.
Product
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
Recall record
Recall number
D-0353-2026
Classification
Class I
Status
Ongoing
Voluntary or mandated
Voluntary: Firm initiated
Firm notification
E-Mail
Distribution
Nationwide in the USA
Recall initiated
2026-01-16
Classified by FDA Center
2026-02-26
FDA published
2026-02-18
Recalling firm
McKesson
Firm location
Irving, TX
Drug identification
Brand name(s)
UDENYCA
Generic name(s)
PEGFILGRASTIM-CBQV
Manufacturer(s)
Accord BioPharma, Inc.
NDC(s)
69448-025, 69448-026, 69448-027
Route(s)
SUBCUTANEOUS
Operational response
A Class I recall indicates a strong likelihood of serious adverse health
consequence or death. Pull affected lots from active dispensing
immediately. Segregate inventory in a marked, locked location pending
destruction or return. If product has already been dispensed, identify
affected patients and contact them by your standard recall-notification
protocol.