Recalled Medicines & supplements – Current GIS Alerts 2026

EUREFIN

Unfavorable benefit-risk ratio of the active substance fenspiride, leading to withdrawal of the reference product and initiation of an EU review. Potential effects: serious adverse reactions, risk to health or life.

ELOFEN

ELOFEN

EURESPAL

Unfavourable benefit–risk balance for the active substance fenspiride; potential public health risk. The French agency (ANSM) initiated an urgent EU review. Potential effects: risk to health or life.

FOSIDAL O SMAKU POMARAŃCZOWYM

An unfavorable benefit-risk ratio was identified for the active substance fenspiride, posing a potential threat to patients’ health or life, justifying immediate suspension of marketing and a temporary ban on placing the product on the market. Potential effects: serious adverse reactions, threat to health or life.

FENSPOGAL

Unfavourable benefit-risk ratio for the active substance fenspiride, causing a potential, real and highly probable risk to patients' health or life, justifying immediate suspension and prohibition of placing the product on the market. Potential effects: serious adverse reactions, complications, life‑threatening events.

EURESPAL

Unfavourable benefit–risk balance of the active substance fenspiride indicated by non-clinical studies. Potential effects: serious adverse reactions, threat to health or life.

EURESPAL

Unfavourable benefit-risk ratio for the active substance fenspiride; potential public health hazard. Potential effects: serious adverse reactions, risk to health or life.

EURESPAL

Unfavourable benefit-risk ratio for the active substance fenspiride; the French agency ANSM initiated an urgent EU re-evaluation procedure. Potential effects: deterioration of health, risk of complications.

EUREFIN

Unfavourable benefit–risk ratio for the active substance fenspiride identified from non-clinical studies; an EU review procedure initiated. Potential effects: serious adverse reactions, threat to health or life.

EURESPAL

Unfavourable benefit-risk balance for the active substance fenspiride, which may pose a public health risk and requires reassessment. Potential effects: serious adverse reactions, risk to health or life.

BUDIXON NEB

Out-of-specification results for the content of budesonide-related substances. Potential effects: reduced efficacy or increased risk of adverse reactions.

BUDIXON NEB

Test results out of specification in archival samples concerning the content of budesonide related substances. Potential effects: reduced efficacy, increased risk of adverse reactions.

BENODIL

Test results out of specification: elevated related substances content of budesonide. Potential effects: reduced efficacy, increased risk of adverse reactions.

BDS N

Out-of-specification results for the content of related substances of budesonide. Potential effects: reduced efficacy or safety of the medicinal product.

BENODIL

Out-of-specification results for related substances of budesonide. Potential effects: reduced efficacy or altered safety of use.

LOREBLOK

Contamination with N-nitroso-N-methylamino butyric acid (NMBA) was detected in some batches of the losartan active substance (from Hetero Labs Limited). Potential effects: increased risk of carcinogenic effects with long-term exposure.

LOREBLOK HCT

Detection of contamination: N-nitroso-N-methylamino-butyric acid (NMBA) in the active substance losartan. Potential effects: long-term carcinogenic risk.

APO-LOZART

Detected contamination of the active substance with N-nitroso-N-methylamino-butyric acid (NMBA), an N-nitrosamine that may affect human health and life. Potential effects: increased cancer risk, systemic toxic effects.

APO-LOZART

Detected contamination with N-nitroso-N-methylamino butyric acid (NMBA) in some batches of the losartan potassium active substance. Potential effects: carcinogenicity, increased long-term health risk.