UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only,… recall
FDA recall D-0353-2026 · initiated Jan 16, 2026
McKesson recalled UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe,… in Jan 2026 — an FDA Class I recall (D-0353-2026) because 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.
Most serious — a reasonable probability that use will cause serious harm or death.
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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 116 cartons
Details
- 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
- Recalling company
- McKesson
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 16, 2026
- FDA report date
- Feb 18, 2026
This recall is linked to a product we cover: Udenyca →
Frequently asked
- Was UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe,… recalled?
- McKesson recalled UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe,… in Jan 2026 — an FDA Class I recall (D-0353-2026) because 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. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe,… recalled?
- Per the FDA enforcement record, the reason for recall D-0353-2026 was: 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.
- Is a recalled UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe,… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe,… are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Subset of Lot 2199821, Expires: 05/31/2027 Specific Serial Numbers being Recalled: 160R694TT06X; 1C74A686RPPG; 1W6A2M777N3V; 20825394KR8P; 242E2RK3EA92; 2DG49VH89EPG; 2WEA2ADK1P4H; 3KR2TVAG3VDH; 42M0V0G9PM84; 46E9XKDPTH1R; 4AM12WEAE48H; 4FGHR096DMNV; 4MWGWM991XNA; 4NEW8XD9DNM2; 4Y2PYDFN9YA1; 61EPX42R4K2A; 63FN9VW5CAV7;…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0353-2026.