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Class II · ModerateActive recall

Gemcitabine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: CB0046, Exp. Date 06/2027
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byTHYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922 foreign manufacturer
Brand nameGEMCITABINE
Generic nameGEMCITABINE
Active ingredient(s)GEMCITABINE HYDROCHLORIDE
Distributed by / forHikma, Berkeley Heights, NJ 07922
NDC0143-9341-01
Show the full FDA record
Full product labelGemcitabine 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 firmMcKesson
DistributionNationwide within the United States
Quantity74 units
Recall initiated2026-06-10
Report date2026-07-08
Recall completed—
Recall numberD-0714-2026
ClassificationClass II
FDA statusOngoing
Origin on fileIrving TX United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.