Medicines recall

Gemcitabine 2g/52.6ml concentrate for solution for infusion

Issued on 4 Sep 2025 · source: MHRA — Medicines and Healthcare products Regulatory Agency

Affected batches: CB0033 (01/05/2026)

Check the batch number on the pack. The medicine remains licensed; other batches are not affected.

Class 4 defect notification · DMRC-35799492 · PL: 15413/0093 · licence holder: Hikma Farmacêutica (Portugal) S.A. · active ingredient: gemcitabine · licence PL: 15413/0093

MHRA alert on GOV.UK ↗ All events: Gemcitabine 2g/52.6ml concentrate for solution for infusion

What this means

The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.

Class 4 defect notification · DMRC-35799492

Product	Licence	Active ingredient	GTIN
Gemcitabine 2g/52.6ml concentrate for solution for infusion	PL: 15413/0093	gemcitabine

Batches (expiry): CB0033 (01/05/2026)

Background: Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions. Gemcitabine 2g/52.6ml concentrate for solution for infusion is administered by Healthcare Professionals within a hospital setting, and most healthcare professionals will already be aware of these serious skin reactions. The missing information is:

Tracked from information published by the MHRA and the NHSBSA. This information is for guidance only and does not replace advice from your doctor or pharmacist.