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Medicines & supplements – Current GIS Alerts 2026

Found 774 alerts in the Medicines & supplements category. Check batch numbers, shops, and hazard information.

Common hazards in this category

All recalled products

Recalled product: XALOPTIC FREE

XALOPTIC FREE

GIF Medium 29.03.2019

It was found that the specification limit for related substances was exceeded in batches of the medicinal product Xaloptic Free, with a likelihood of this non‑compliance occurring in further batches. Potential effects: possible lack of efficacy or unforeseen adverse reactions.

Recalled product: IRCOLON FORTE

IRCOLON FORTE

GIF Low 26.03.2019

Only a labelling error of the expiry date was found (02.2021 instead of 02.2020), with no indication of quality or safety hazards for the product. After confirmation of shelf-life extension to 3 years, the risk was considered negligible. Potential effects: none or minimal risk, possibly uncertainty about the actual expiry date.

Recalled product: ROTARIX

ROTARIX

GIF High 22.03.2019

Irregularities in the manufacturing process were detected, leading to possible insufficient filling of the last 50 oral applicators of the Rotarix batch, meaning failure to meet quality requirements for the volume parameter. Potential effects: lack of vaccination efficacy.

Recalled product: BENZACNE

BENZACNE

GIF Medium 19.03.2019

A quality defect of the product was found regarding the gel appearance and active substance content, resulting from a defect of the immediate packaging, which may lead to improper quality and performance of the product. Potential effects: lack of treatment efficacy or unpredictable drug action.

Recalled product: BENODIL

BENODIL

GIF Medium 15.03.2019

Out-of-specification results were found in archival samples tested by the manufacturer, regarding the parameter of budesonide-related substances content, which means failure to meet established quality requirements. Potential effects: possible lack of treatment efficacy or unforeseen adverse reactions.

Recalled product: BENODIL

BENODIL

GIF Medium 15.03.2019

A quality defect was identified consisting of out-of-specification results for the parameter of budesonide-related substances content, which may indicate an improper impurity profile and lack of compliance with quality requirements. Potential effects: possible reduced treatment efficacy or increased risk of adverse reactions.

Recalled product: PRESARTAN

PRESARTAN

GIF Critical 12.03.2019

Impurities of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) were detected in the active substance Losartanum kalicum from the manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd. Potential effects: possible carcinogenic effects and health risks with long-term use.

Recalled product: PRESARTAN H

PRESARTAN H

GIF Critical 12.03.2019

The risk may be caused by the presence of nitrosamine-group contaminants in the active substance contained in these medicinal products, which may affect human health and life. Potential effects: possible carcinogenic effects, chronic health risk, potential complications with long-term use.

Recalled product: PRESARTAN H

PRESARTAN H

GIF Critical 12.03.2019

Detected nitrosamine-group impurities (NDMA and NDEA) in the active substance losartan potassium, which may affect human health and life, even though the levels do not exceed acceptable limits. Potential effects: possible carcinogenic effects and health complications with long-term use.

Recalled product: PRESARTAN

PRESARTAN

GIF Critical 12.03.2019

This risk may be caused by the presence of nitrosamine-group impurities in the active substance contained in the above-mentioned medicinal products, which may affect human health and life. Potential effects: possible carcinogenic effects and health complications during long-term use.

Recalled product: KORZEŃ ARCYDZIĘGLA

KORZEŃ ARCYDZIĘGLA

GIF Medium 07.03.2019

Failure to meet quality requirements of the medicinal product was found due to the presence of disqualifying features, which makes a potential risk to patients’ health or life plausible. Potential effects: lack of efficacy, possible adverse effects or health complications.

Recalled product: GLICEROL

GLICEROL

GIF Medium 14.02.2019

Out-of-specification results were found for aldehydes, sugars, impurity A and related substances during stability testing of batch 01916, which makes a potential threat to the quality and safety of the medicinal product plausible. Potential effects: lack of efficacy or unforeseen adverse reactions.

Recalled product: EURESPAL

EURESPAL

GIF Critical 11.02.2019

Unfavorable benefit-risk balance of the active substance fenspiride shown in non-clinical studies. Potential effects: threat to patients' health or life.

Recalled product: PULNEO O SMAKU COLI

PULNEO O SMAKU COLI

GIF Critical 11.02.2019

An unfavourable benefit-risk ratio for the active substance fenspiride, potentially posing a risk to patients’ health or life, with the probability of harm to a person considered significant. Potential effects: serious adverse reactions, complications, threat to health or life.

Recalled product: EUREFIN

EUREFIN

GIF Critical 11.02.2019

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.

Recalled product: PULNEO O SMAKU COLI

PULNEO O SMAKU COLI

GIF Critical 11.02.2019

An unfavourable benefit-risk balance was identified for the active substance fenspiride, which may represent a real and highly probable risk to patients’ health or life. Potential effects: serious adverse reactions, risk to health or life.

Recalled product: EURESPAL

EURESPAL

GIF Critical 11.02.2019

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.

Recalled product: EURESPAL

EURESPAL

GIF Medium 11.02.2019

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.

Recalled product: FENSPOGAL

FENSPOGAL

GIF Critical 11.02.2019

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.

Recalled product: EURESPAL

EURESPAL

GIF Critical 11.02.2019

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

What to do if you bought a recalled product?

If you have purchased any of the products listed above, stop using or consuming them immediately. You can return the product to the store where you bought it for a full refund. Keep the receipt if possible, but most stores will accept returns even without one.