Recalled medicines and products GIF — current list 2026
GIF — Chief Pharmaceutical Inspectorate
GIF (the Chief Pharmaceutical Inspectorate) issues decisions to suspend and withdraw medicines and pharmaceutical products from the market when quality, safety or batch problems arise. The list below brings together medicines recalled by the Chief Pharmaceutical Inspectorate in one place and is updated continuously.
353 alerts in the database • last update:
Latest recalled products from GIF
Champix
the finding of N-nitroso-varenicline above the limits set by the COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP). Potential effects: possible long-term toxic effects, including an increased risk of cancer.
Valzek
An exceeded limit was found for the impurity 5-(4'-(azidomethyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole in batches of the active substance used to manufacture Valzek (Valsartan) tablets. Potential effects: possible toxic effects of the impurity and a health risk to patients.
Valzek
An exceedance of the limit for the impurity 5-(4'-(azidomethyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole was found in batches of the active substance used to manufacture the product. Potential effects: poisoning, toxic effects, serious adverse reactions.
Lakea
Exceeding the limit of impurity 5-[4'-[(5-(azidomethyl)-2-butyl-4-chloro-1H-imidazol-1-yl)methyl]-[1,1'-biphenyl]-2-yl]-1H-tetrazole was found in the active substance used to manufacture the tablets. Potential effects: possible toxic effects and lack of full therapy safety.
Mitocin 20 mg
In batch no. 0-20022AB an out-of-specification result was found due to the presence of visible particles in the product intended for solution for injection. Potential effects: embolism, inflammation, inflammatory reactions, local or systemic complications.
Ciprofloxacin Kabi 400 mg/200 ml roztwór do infuzji
It was found that Ciprofloxacin Kabi cartons contained bottles labeled Glucosum 5% Fresenius with the same batch number, indicating mix-up of infusion products and risk of administering the wrong medicine. Potential effects: lack of efficacy, infusion-related complications.
Arpixor
According to the MAH’s representative, there is a justified suspicion that the Arpixor 30 mg, 56 tablets batch does not meet quality requirements regarding appearance. Potential effects: lack of treatment effectiveness or unpredictable drug action.
Arpixor
The abnormal appearance of the tablets does not meet the product’s quality requirements and may lead to interruption of pharmacotherapy, which in turn may pose a risk to patients’ life or health. Potential effects: worsening of the disease, complications, risk to life or health.
Bisoratio ASA
Out-of-specification results were found for the parameter of related substances and total bisoprolol impurities during long-term 12‑month stability studies, which may affect the safety and efficacy of the medicine. Potential effects: reduced treatment effectiveness, adverse reactions, cardiovascular complications.
Apo-Simva 40
A confirmed out-of-specification result was found for cross-contamination of the medicinal product with acetylsalicylic acid and salicylic acid. Potential effects: risk of adverse effects, allergic reactions, bleeding or other complications due to unintended intake of additional active substances.
Ozzion
An out-of-specification result was found for the release parameter, meaning the drug may not release the active substance correctly and may not ensure effective therapy. Potential effects: lack of treatment efficacy, worsening of symptoms, complications.
Champix
The presence of N-nitroso-varenicline contamination was found in the bulk product batch, with the level of this impurity exceeding the limit set based on ICH M7 guidance. Potential effects: possible carcinogenic effect and other serious adverse reactions.
Amiodaron Hameln
Particles were detected in some ampoules of the concentrate for solution for injection or infusion, which according to the specification should be clear, light yellow and free from visible particles. Potential effects: risk of emboli, local reactions, circulatory complications or other serious complications during intravenous administration.
Flutixon Neb
An out-of-specification result was found regarding the content of related substances in the medicinal product Flutixon Neb. Potential effects: reduced treatment efficacy or unpredictable adverse reactions.
Flutixon Neb
An out-of-specification result was found for the content of related substances in the product batches, which constitutes a quality defect and a potential risk to patients' health. Potential effects: possible adverse reactions, altered treatment efficacy, unpredictable bodily responses.
Petroleum D4
Incorrect expiry date labelling was found: the packaging shows 02.2022, while the correct date is 09.2022. Potential effects: possible premature disposal of the medicine or doubts about its validity.
Lignocain 2%
A foreign body was identified in an individual immediate container, i.e. in a 20 ml vial of the Lignocain 2% solution for injection. Potential effects: infection, inflammatory reactions, local and systemic complications, including life-threatening conditions.
Febrisan
A quality defect was found consisting of micro-damages in the structure of the primary packaging foil, which may lead to loss of tightness and deterioration of the medicine’s quality. Potencjalne skutki: reduced treatment efficacy or adverse reactions.
Silimax
Irregularities in batch number labelling were found: containers with batch number 05022020 were packed into cartons incorrectly marked as 02022020, preventing unambiguous identification of the product batch. Potential effects: risk of mix-ups and hindered recall in case of safety issues.
Bufomix Easyhaler
A quality defect was identified in the Easyhaler inhaler, in the reservoir chamber containing the inhalation powder; as a defect of the immediate packaging it may affect the medicinal product quality and dose delivery. Potential effects: lack of treatment efficacy, possible worsening of disease symptoms.
Formoterol Easyhaler
A quality defect of the Easyhaler inhaler was found in the reservoir chamber containing the inhalation powder; the impact of this defect on the quality and correct dosing of the medicinal products cannot be excluded, creating a potential risk to patients’ health or life. Potential effects: lack of efficacy, disease exacerbation, respiratory complications.
Nitroxolin forte
An impurity 5,7-Dinitro-8-quinolinol (DNC) was identified in the active substance and classified as a mutagenic impurity, whose content should be lower than currently approved limits. Potential effects: increased risk of DNA damage, cancer and other complications.
Hemkortin-HC
Incorrect strength of the medicinal product was found on the immediate (tube) packaging, which may mislead patients or medical staff about the dose being used. Potential effects: improper dosing, lack of therapeutic efficacy or increased adverse reactions.
Biodacyna
A quality defect was found: an out‑of‑specification result for the colour parameter in a parenterally administered medicinal product, which entails a potential risk to patients’ health or life. Potential effects: complications after intravenous or intramuscular administration, lack of treatment safety.
Tlen medyczny Air Products
An unusual odour was detected in one of the cylinders from the batch of the medicinal product Medical oxygen Air Products, indicating a quality defect of the medical gas and a potential health risk to patients when used. Potential effects: irritation of the respiratory tract, unspecified adverse reactions, lack of safety of oxygen therapy.
Zerbaxa
Microbiological contamination was detected in batches of Zerbaxa, indicating a quality defect that may pose a real risk to patients’ health or life. Potential effects: infection, sepsis, treatment complications, lack of therapeutic efficacy.
Tramal
A quality defect was found consisting of unglued outer packaging of the product, which may affect the safety and correct use of the medicine. Potential effects: possible compromise of packaging integrity, risk of improper use or dosing errors.
Triderm
The occurrence of incorrect information on the outer packaging regarding the repackaging site and the name of the parallel importer was classified as a quality defect of the medicinal product. Potential effects: incorrect use of the drug, inability to identify the responsible entity, possible therapy complications.
Lisinoratio 5
Suspected contamination of the batch of Lisinoratio 5, 5 mg, tablets with ibuprofen as an undesired substance, which is a potential quality defect that may endanger patients’ health. Potential effects: adverse reactions, drug interactions, complications involving kidneys and cardiovascular system.
Oxydolor
Stability studies of the product batches showed an out-of-specification result for active substance content, which may lead to incorrect dosing of the medicine. Potential effects: lack of treatment efficacy or overdose, complications, risk to health.
Krople uspokajające spokojne
the tested sample of the medicinal product Krople uspokajające spokojne did not meet the requirements specified in the product documentation for total aerobic microbial count (TAMC). This quality defect may pose a potential risk to the health or life of patients. Potential effects: infections, complications, health risk.
Gliceryna
It was found that test results for batches of the pharmaceutical raw material GLICERYNA 85% are out of specification for the parameters: aldehydes and sugars, which means failure to meet established quality requirements for a medicinal product. Potential effects: reduced quality of preparations, possible irritation or other adverse reactions.
Timo-COMOD 0,5 %
Irregularities in the assembly of the dispenser pump housing were found, resulting in improper drop size or inability to dispense drops from the dispenser. Potential effects: lack of treatment efficacy, incorrect dosing, possible worsening of the eye condition.
Allergo-Comod
Irregularities in the assembly of the dispenser pump housing were found, causing incorrect drop size or inability to dispense drops from the bottle. Potential effects: lack of treatment efficacy, worsening of allergy symptoms, possible discomfort or eye irritation.
Octostim
Incorrect volume was detected in some packs and out-of-specification results for the content of the active substance desmopressin and the excipient benzalkonium chloride. Potential effects: lack of treatment efficacy or adverse effects due to incorrect dosing.
Minirin
In some packs, an incorrect liquid volume and results not complying with the specification for desmopressin and benzalkonium chloride content were found, meaning the dose and safety of the product cannot be assured. Potential effects: lack of treatment efficacy or overdose, adverse reactions, complications.
Dicortineff
Occurrence of a quality defect in the medicinal product in the fludrocortisone acetate parameter, confirmed in stability testing and an archival sample. Potential effects: possible lack of treatment efficacy or unpredictable adverse reactions.
Ventolin
The quality defect consists in marking the batch with a unique identifier indicating in the system that the batch is withdrawn, which prevents dispensing the product to patients and may lead to lack of availability of the medicine. Potential effects: lack of effective treatment, deterioration of health.
Megalia
Out-of-specification results were found regarding microbiological purity in batches of the medicinal product Megalia. Potential effects: infection, complications, risk to patients' health.
Uromaste
Use of the product, for which the benefit–risk balance was assessed as negative, poses a threat to public health; there is a significant probability of real harm to patients’ health or life. Potential effects: treatment complications, lack of efficacy, threat to health or life.
Monural
Use of this product, for which the benefit–risk ratio has been considered negative, poses a threat to public health. Potential effects: serious adverse reactions, health risk, possible complications.
Nasen
A quality defect consisting in placing in the outer packaging of one medicinal product the blisters of another medicinal product, creating a risk that the patient will take the wrong medicine. Potential effects: inappropriate treatment, lack of therapeutic efficacy, serious adverse reactions.
Furosemidum Polfarmex
The quality defect involves a mix-up of Furosemidum Polfarmex and Nasen packs, creating a risk that patients take the wrong medicine and consequently face a threat to their life or health. Potential effects: lack of efficacy, increased adverse effects, serious complications, life-threatening situations.
Sulfarinol
An out-of-specification result was obtained in stability testing for batch 020618 concerning the parameter “naphazoline nitrate contamination – other single impurity”, with the possibility that this quality defect may occur in other batches still on the market. Potential effects: nasal mucosa irritation, adverse reactions or reduced treatment effectiveness.
Groprinosin Max
Out-of-specification results were found in antimicrobial preservation efficacy tests for Groprinosin MAX, meaning lack of adequate preservation and a risk of infection after use. Potential effects: infections, complications, health risk for patients.
Cisatracurium Noridem
The tested sample of the medicinal product does not meet the requirements specified in the documentation for active substance content and product appearance, which creates a potential risk to patients' health or life. Potential effects: lack of treatment efficacy, complications during anaesthesia, life-threatening risk.
Megalia
Failure to meet quality requirements for the batch regarding microbiological purity, which poses a potential risk to patients’ health or life and was the basis for granting the decision immediate enforceability. Potential effects: infection, complications, lack of treatment safety.
Montelukast Bluefish
A discrepancy was found between the outer packaging and the Summary of Product Characteristics – a product intended for children aged 6–14 years was labelled as for children 2–5 years, which poses a threat to public health. Potential effects: improper use in children, risk of lack of efficacy or adverse effects.
Ebetrexat
It was found that the sample did not meet the product specification requirements for purity; the out-of-specification result concerned the parameter "content of related substance impurities". Potential effects: altered drug effect, possible increased adverse reactions or complications of therapy.
Megalia
Failure to meet quality requirements for this batch was found regarding the microbiological purity parameter, which may indicate the presence of microorganisms in the product and a potential risk to patients' health. Potential effects: infections, adverse reactions, lack of treatment efficacy.
Saridon
It was found that the packaging materials do not meet requirements – some packs of the product are labeled in Hungarian, which may lead to misunderstanding of information about the medicine. Potential effects: incorrect use of the medicine, lack of efficacy, complications.
Reseligo
A result out of specification was found for active substance content, indicating a quality defect that may lead to improper drug action. Potential effects: treatment failure or adverse reactions.
Sulfarinol
Out-of-specification results were found in tested archival samples for the listed Sulfarinol batches regarding the parameter naphazoline nitrate impurity – another single impurity. Potential effects: possible adverse reactions, lack of efficacy or other complications related to uncontrolled impurity.
Sulfarinol
Out-of-specification results were found in archival samples for the parameter naphazoline nitrate contamination – another single impurity, which creates a potential risk to patients’ health or life. Potential effects: mucosal irritation, systemic adverse effects, lack of therapeutic efficacy.
Tetmodis
Out-of-specification results were found for active substance content in batch T1702PL of Tetmodis (Tetrabenazine), which may mean an inappropriate dose for the patient. Potential effects: lack of efficacy or increased adverse effects.
Sulfarinol
Out-of-specification results were found in archival samples of Sulfarinol batches for the parameter “naphazoline nitrate contamination – other single impurity”, indicating a quality defect of the product. Potential effects: reduced treatment efficacy and possible adverse reactions of unpredictable intensity.
Mitomycin Accord
A quality defect was found consisting in the inability to dissolve the powder, which may prevent preparation of a correct injection/infusion solution and result in failure to administer the proper drug dose. Potential effects: lack of treatment efficacy, complications of oncological therapy.
Sulfarinol
The tested retention samples showed out-of-specification results for the parameter “naphazoline nitrate contamination – other single impurity”, which may indicate the presence of an undesirable chemical compound in the product. Potential effects: possible adverse effects, irritation, lack of efficacy or other unpredictable reactions.
Espumisan 100 mg/ml
In several packs of the product, information leaflets for the medicinal product Zentel were detected instead of the correct Espumisan leaflet. Potential effects: incorrect use of the medicine, risk of improper dosing or lack of treatment efficacy.
Riflux
Contamination of the active substance Ranitidine with N-nitrosodimethylamine (NDMA) was detected, constituting a quality defect and a potential risk to patients’ health. Potential effects: possible toxic and carcinogenic effects during long-term use.
Recalls by source
Frequently asked questions
What are GIF alerts?
GIF (Chief Pharmaceutical Inspectorate) alerts are decisions to suspend or withdraw medicines and pharmaceutical products from the market due to quality or safety issues.
What to do if you bought a recalled product?
Stop using or consuming the product immediately. Most recalled products can be returned to the store for a full refund, even without a receipt. On each alert page you will find a direct link to the official report with detailed information from the authorities.
What to do if you have this product?
A recall means the product may be unsafe. Here is what to do if you have it at home.
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1
Do not eat or use the product
Stop using or consuming it immediately and keep it out of reach of children.
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2
Check the batch number and expiry date
Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
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3
Return it to the shop
You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
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4
Get help and report it
If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.
General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.