FDA recall, , Moderate risk
Hikma Gemcitabine Injection
Gemcitabine Injection was stored incorrectly.
Summary by Recall Canary from the FDA notice
What happened
McKesson, of Irving, Texas, recalled Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, because the product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment. The recall began on June 10, 2026, and the product was distributed nationwide within the United States.
The recalled product is manufactured by THYMOORGAN PHARMAZIE GmbH and distributed by Hikma. The recall involved 74 units and was added to the FDA's Enforcement Report on July 1, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Gemcitabine Injection
- NDC
- 0143-9341-01
- Lot code
- CB0046
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- McKessonIrving, Texas
- Hazard
- Processing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99262
- Recall number
- D-0714-2026
- Quantity recalled
- 74 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
