Lower riskDrug recall · FDA · Published January 16, 2026
McKesson Recalls UDENYCA Injection Due to Temperature Abuse Risk
McKesson recalls specific UDENYCA injections (6 mg/0.6mL) manufactured by Accord BioPharma that were stored incorrectly in non-refrigerated conditions. This may affect product safety.
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.
Take action
Contact the company
📍Recalling firmMcKesson6555 State Highway 161 · Irving, TX 75039-2402
“McKesson Recalls UDENYCA Injection Due to Temperature Abuse Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31551-mckesson-recalls-udenyca-injection-due-to-temperature-abuse-risk. Based on FDA recall #D-0353-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0353-2026%22&limit=1).
The FDA announced on Jan. 16, 2026, that McKesson is recalling UDENYCA, pegfilgrastim-cbqv injection due to temperature abuse hazards. The recall affects 116 cartons of Lot 2199821 stored incorrectly at room temperature instead of refrigerated conditions.
How to tell if you have it
Brand: McKesson
Product: UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe
NDC: 69448-025-63
Lot: 2199821
Expiration: 05/31/2027
Quantity: 116 cartons
Distribution: Nationwide in the USA
The hazard
According to the FDA, 116 cartons with specific serial numbers of Lot 2199821 were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment. This temperature abuse poses a risk to the product's integrity.
Context
GovInfoNow's records show McKesson has three other recalls on record since Sept. 12, 2014. Other recent recalls include McKesson Gemcitabine Injection Recall (June 10, 2026) and McKesson Inflectra (infliximab-dyyb) Recall (Jan. 17, 2025). Other recent recalls of similar products include Asclemed Lidocaine HCl Injection Recall (June 8, 2026), Somerset Therapeutics Dexamethasone Injection Recall (Feb. 4, 2026), and Fresenius Kabi 0.9% Sodium Chloride Injection Recall (March 11, 2026).
How to tell if you have this one
Check for specific serial numbers listed in the recall notice: 160R694TT06X, 1C74A686RPPG, and other serial numbers provided in the record. The product was manufactured by Accord BioPharma and expires May 31, 2027.
Brand
McKesson
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Serial Number
Look for the specific serial numbers listed in the recall notice to determine if your UDENYCA injection is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class I
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0353-2026 (January 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0353-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.