CLASS II ONGOING Drug recall · Reported 8 Jul 2026 · FDA Enforcement Report
Gemcitabine Injection per (38 mg/mL) Single-Dose Vial recalled
McKesson is recalling Gemcitabine Injection per (38 mg/mL) Single-Dose Vial, For Intravenous Infusion ONLY, distributed nationwide in the US. The recall was initiated on 10 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0714-2026
- FDA event ID
- 99262
- Recalling firm
- McKesson, Irving, TX
- Brand
- Gemcitabine
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jun 2026
- FDA classified
- 21 Jul 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Temperature Abuse
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Jun 2026 | Recall initiated by company | |
| 8 Jul 2026 | Published in enforcement report | +28 days |
| 21 Jul 2026 | Classified by FDA | +13 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Which lots are affected?
Lot #: CB0046, Exp. Date 06/2027
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from McKesson
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Udenyca, pegfilgrastim-cbqv injection recalled by McKessonUdenyca | McKesson | Temperature Abuse | Nationwide |
| Drug | CLASS II | Inflectra (infliximab-dyyb), For injection, 100mg per vial recalledInflectra | McKesson | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cabtreo (clindamycin phosphate, adapalene recalled by MckessonCabtreo | Mckesson | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) recalled | McKesson | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Prilocaine Cream USP, 2.5%/2.5% recalled by McKesson | McKesson | Potency & Assay | Nationwide |
Other Gemcitabine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gemcitabine, Sterile Intravesical Solution recalled by Edge Pharma | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Gemcitabine Injection 200mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Gemcitabine 1910 MG / NS IVPB recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS I | Gemcitabine for Injection, USP*/vial, Lyophilized powder recalled | Mylan Institutional | Particulate Matter | Nationwide |
| Drug | CLASS I | Gemcitabine for Injection, USP, 200 mg*/vial recalled | Mylan Institutional | Particulate Matter | Nationwide |