FDA-Drug2026-02-18Class IPROCESSING DEFECT
McKesson UDENYCA pegfilgrastim injection recalled for temperature storage abuse
OTHERNationwide distribution
Check your UDENYCA injection lot and serial number
McKesson's UDENYCA (pegfilgrastim-cbqv) injection was stored at room temperature instead of in the refrigerator, which may have reduced its effectiveness. This affected 116 cartons from Lot 2199821 with specific serial numbers. The FDA classified this as a Class I recall.
- Check if your UDENYCA matches Lot 2199821 and one of the listed serial numbers
- If it does, do not use it—contact your pharmacist or doctor immediately
- Ask your healthcare provider for a replacement dose
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.
Sold states
Nationwide in the USA
Affected count
116 cartons
Manufactured in
6555 State Highway 161, N/A, Irving, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0353-2026Don't want to check this manually?
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