Class II · Moderate risk
Neupogen (filgrastim)
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Udenyca (Pegfilgrastim-Cbqv)
Class I — High risk. Reasonable probability of 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.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
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
Affected NDC
69448-0025-63
Compare with the code on your package — it is the most precise check available.
Drug: Filgrastim
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Udenyca pegfilgrastim-cbqv NDC 69448-0025 |
PEGFILGRASTIM 6 mg/.6mL | Injection, Solution Subcutaneous |
Accord BioPharma, Inc. | Rx |
- Recalling firm
- McKesson
- NDC code
- 69448-025-63
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0353-2026 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Filgrastim recalls
See all
Class II · Moderate risk
Neupogen (filgrastim)
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class II · Moderate risk
Granix (tbo-filgrastim)
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Other recalls by McKesson
All 2026 recalls
Class II · Moderate risk
Gemcitabine Injection
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Class II · Moderate risk
Inflectra (infliximab-dyyb)
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Class II · Moderate risk
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide)
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Class II · Moderate risk
Erythromycin Topical Gel USP
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
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