FDA recall, , High risk
Accord BioPharma Udenyca Prefilled Syringe
Udenyca injection was stored at room temperature instead of refrigerated.
Summary by Recall Canary from the FDA notice
What happened
McKesson, of Irving, Texas, recalled UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, manufactured by Accord BioPharma, Inc., because 116 cartons with specific serial numbers were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment. The recall began January 16, 2026, and was added to the FDA's Enforcement Report on February 10, 2026.
The product was distributed nationwide in the USA. The FDA classified the recall on February 26, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe
- NDC
- 69448-025-63
- Lot code
- 2199821
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- McKessonIrving, Texas
- Hazard
- Processing problem
- Risk
High risk
There is a reasonable chance that taking it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98366
- Recall number
- D-0353-2026
- Quantity recalled
- 116 cartons
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Listed on Recall Canary
Summary updated
