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CLASS II · ModerateFDA

McKesson recalls Gemcitabine Injection

📅 Jun 10, 2026 · 📍 Nationwide
Recalling company
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 – may cause temporary or medically reversible health consequences
Recall date
Jun 10, 2026
Reported
Jul 8, 2026
Distribution
Nationwide within the United States
Status
Ongoing
Quantity
74 units
Lot / codes
Lot #: CB0046, Exp. Date 06/2027
Company location
Irving, TX
Recall type
Voluntary: Firm initiated
Recall number
D-0714-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0714-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.