Mckesson: Gemcitabine Injection

McKesson is recalling Gemcitabine Injection (a cancer medication) distributed nationwide because the drug was stored at room temperature instead of in refrigeration, which may have compromised its effectiveness. The affected product is a 1-gram vial with NDC number 0143-9341-01, distributed by Hikma. This is a Class II recall, meaning use of the product could result in serious health consequences or death.

Recalling firm
McKesson
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.
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-06-10
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide within the United States

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/67e08fb0-fe89-4549-88a6-b29f68d79e60