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Gemcitabine Injection
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DRUG RECALLMODERATE

Gemcitabine Injection

Hikma is recalling Gemcitabine Injection due to improper temperature storage.

What to do

Contact your healthcare provider or pharmacy if you have concerns about this medication. Do not use the affected product.

Posted
Updated
Recall No.
D-0714-2026
Agency
Firm
McKesson
Recall ID
99262
Status
ONGOING

Why it was recalled

Hikma is recalling Gemcitabine Injection due to temperature abuse. The product was stored in a controlled room temperature environment instead of the required refrigerated conditions.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

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

Recall #
D-0714-2026

Where it was sold

Distributed nationwide.

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Editorial summary by Recall Canary · last updated 2026-07-22 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification