McKesson Recalls Gemcitabine Injection Vials Over Temperature Abuse

McKesson has voluntarily recalled 74 units of Gemcitabine Injection after the chemotherapy drug was stored at controlled room temperature instead of the required refrigerated conditions, potentially compromising its safety and effectiveness.

What Products Are Being Recalled?

The recall covers Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), packaged in 26.3 mL Single-Dose Vials for intravenous infusion only. The product is manufactured by THYMOORGAN PHARMAZIE GmbH in Goslar, Germany, and distributed by Hikma in Berkeley Heights, NJ. The affected NDC is 0143-9341-01, with Lot number CB0046 and an expiration date of 06/2027.

Why Was This Recall Issued?

The recall was initiated due to ‘temperature abuse.’ The product was stored incorrectly in a controlled room temperature environment rather than the refrigerated environment required to maintain the drug’s stability and quality. Gemcitabine Injection that has not been properly refrigerated may experience degradation, which could reduce its effectiveness or introduce safety concerns for patients receiving the treatment.

Who Is Affected?

The recall affects 74 units distributed nationwide within the United States. McKesson, headquartered in Irving, TX, is the recalling firm. This is a voluntary, firm-initiated recall, and the FDA event listing indicates the recall status is currently ongoing. The classification for this recall has not yet been determined.

What Should You Do?

Consumers, pharmacies, and healthcare facilities in possession of ‘Gemcitabine Injection’ with Lot number CB0046 should immediately stop using and distributing the affected vials. Facilities should quarantine the product and check inventory against the lot number and NDC listed above. Contact McKesson directly for guidance on returning or disposing of the affected units and for information on replacement stock. Healthcare providers who have administered product from this lot to patients should monitor for any adverse reactions and report concerns to the FDA’s MedWatch program.

Official Statement

According to the FDA enforcement report, McKesson notified consignees of the recall by telephone. No press release has been issued for this recall at this time. The recall initiation date is listed as 6/10/2026, and the event remains ongoing with no termination date recorded.