# FDA recall D-0353-2026

> **McKesson** · Class I · drug recall initiated 2026-01-16.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0353-2026
- **Recalling firm:** McKesson
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-01-16
- **Report date:** 2026-02-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0353-2026

## Citation

> AI Analytics. FDA recall D-0353-2026. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0353-2026. Source: US FDA. Licensed CC0.

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