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High risk Drugs & MedicationsClass I

UDENYCA Pegfilgrastim Lot 2199821 Recall

UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco

Updated January 16, 2026

UDENYCA (pegfilgrastim-cbqv) injection, a prescription drug used to boost white blood cell counts, is being recalled because 116 cartons from Lot 2199821 were stored at room temperature instead of the required refrigerated conditions. Improper storage can degrade the medication, meaning it may no longer work as intended, a serious risk for patients who depend on it.

Is the McKesson recalled? Yes. This product was recalled by FDA on January 16, 2026. Details below.

What is recalled

UDENYCA (pegfilgrastim-cbqv) injection, 6 mg/0.6 mL, Single Dose Prefilled Syringe, Rx only. Manufacturer: Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617. NDC: 69448-025-63. Lot number: 2199821 (116 cartons with specific serial numbers within this lot). Distributed by McKesson.

Am I affected

You may be affected if you received or dispensed UDENYCA (pegfilgrastim-cbqv) 6 mg/0.6 mL prefilled syringes with NDC 69448-025-63 and Lot 2199821 printed on the carton or syringe label. Check the lot number on your packaging, only the 116 cartons with specific serial numbers within Lot 2199821 are included.

What to do right now

Stop using this product immediately if you have cartons from Lot 2199821 (NDC 69448-025-63). Return them to where you obtained them or contact your healthcare provider or pharmacist right away. Because no consumer contact information was provided in this recall, patients should speak with their prescribing doctor before missing or delaying a dose so an alternative can be arranged.

The hazard

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.

Brands affected

McKesson
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0353-2026
Classification
Class I
Recalled
January 16, 2026
Read the official notice

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