FDAFDA recall D-0714-2026 · Jul 8, 2026
McKesson: Gemcitabine Injection recall
Recall found
Product
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
Reason for recall
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: CB0046, Exp. Date 06/2027
- Quantity
- 74 units
- Distribution
- Nationwide within the United States
- Recalling firm
- McKesson, Irving, TX
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-10
Source: openFDA enforcement record D-0714-2026 · search recall number D-0714-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.