Lower risk Drug recall · FDA · Published June 10, 2026

McKesson Gemcitabine Injection Recall: Temperature Storage Risk

McKesson recalls Gemcitabine injection vials stored at room temperature instead of refrigerated. This could affect cancer treatment safety. Check your NDC 0143-9341-01 lot CB0046 for affected units.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0714-2026Drug McKesson ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmMcKesson6555 State Highway 161 · Irving, TX 75039-2402

✎ GovInfoNow plain-language explainer

McKesson is recalling Gemcitabine injection vials that were stored at room temperature instead of refrigerated. This could lead to improper drug concentration affecting cancer treatment safety. Patients using this medication should contact their healthcare provider for guidance. Read more at govinfonow.com/recall/31211-mckesson-gemcitabine-injection-recall-temperature-storage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31211-mckesson-gemcitabine-injection-recall-temperature-storage-risk · Updated August 10, 2026 · FDA enforcement record: FDA #D-0714-2026

Cite this page

“McKesson Gemcitabine Injection Recall: Temperature Storage Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31211-mckesson-gemcitabine-injection-recall-temperature-storage-risk. Based on FDA recall #D-0714-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0714-2026%22&limit=1).

The FDA announced on June 10, 2026, that McKesson is recalling Gemcitabine Injection due to temperature abuse hazards. The agency issued recall number D-0714-2026 for the voluntary Class II recall.

How to tell if you have it

Brand: McKesson
Product: Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial
NDC: 0143-9341-01
Lot #: CB0046
Exp. Date: 06/2027

The hazard

The product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment, according to the FDA.

Context

GovInfoNow's records show McKesson has 3 other recalls on record since 2026-01-16. Other recent recalls of similar products include Sagent Busulfan Injection Recall: Failed Impurities Risk (2026-05-04), Somerset Therapeutics Dexamethasone Injection Recall: Impurities May Cause Harm (2026-02-04), and Baxter Vancomycin Injection Recall: CGMP Deviations Risk (2026-08-06).

How to tell if you have this one

Check for the NDC code 0143-9341-01 and lot number CB0046 on the vial label. This product was distributed by Hikma and manufactured by Thymoorgan PharmaZie GmbH in Germany.

Brand
McKesson
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Vial Label
Look for the NDC code 0143-9341-01 and lot number CB0046 on the vial label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 28 days after the firm started it.

Jun 10, 2026Firm started the recall
Jul 8, 2026Published in FDA’s Enforcement Report
Jul 21, 2026FDA classified it Class II

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31211-mckesson-gemcitabine-injection-recall-temperature-storage-risk">McKesson Gemcitabine Injection Recall: Temperature Storage Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0714-2026 (June 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0714-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.