Recall: D-0714-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-10Initiated

OngoingStatus

McKessonFirm

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

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.