UDENYCA recalled over temperature-control failures

Recall date

January 16, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

McKesson recalls UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPha…

Recall number

D-0353-2026

FDA classification

Class I

Brand / firm

McKesson

Sold / distributed

Nationwide in the USA

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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