# FDA recall D-0714-2026

> **McKesson** · Class II · drug recall initiated 2026-06-10.

## Product

Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922.  NDC: 0143-9341-01

## Reason for recall

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0714-2026
- **Recalling firm:** McKesson
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-06-10
- **Report date:** 2026-07-08

- **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-0714-2026

## Citation

> AI Analytics. FDA recall D-0714-2026. Retrieved 2026-09-02 from https://api.ai-analytics.org/recall/D-0714-2026. Source: US FDA. Licensed CC0.

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