UDENYCA — Class I drug recall D-0353-2026
Ongoing recall by McKesson, reported 2026-02-18, distributed nationwide. Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a contr
| Recall number | D-0353-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | McKesson, Irving, TX, United States |
| Recall initiated | 2026-01-16 |
| Classified | 2026-02-26 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 116 cartons |
| Reason classes | temperature control |
| NDC | 69448-0025, 69448-0025-63, 69448-0026, 69448-0026-63, 69448-0027, 69448-0027-63 |
| Lot numbers | 2199821 |
| Expiration dates | 2027-05-31 |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0353-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.