Gemcitabine Injection recall
FDA recall D-0714-2026 · initiated Jun 10, 2026
McKesson recalled Gemcitabine Injection in Jun 2026 — an FDA Class II recall (D-0714-2026) because Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 74 units
Details
- 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
- Recalling company
- McKesson
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jun 10, 2026
- FDA report date
- Jul 8, 2026
Frequently asked
- Was Gemcitabine Injection recalled?
- McKesson recalled Gemcitabine Injection in Jun 2026 — an FDA Class II recall (D-0714-2026) because Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Gemcitabine Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0714-2026 was: Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
- Is a recalled Gemcitabine Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Gemcitabine Injection are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: CB0046, Exp. Date 06/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0714-2026.