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
Debridat
A potential quality defect was reported due to the risk of a foreign body being present in the product, which may pose a real and direct risk to patients’ health or life. Potential effects: complications, tissue damage, life-threatening events.
Debridat
Risk of a quality defect in the medicinal product Debridat, 7.87 mg/g, granules for oral suspension, due to the risk of the presence of a foreign body in the product. Potential effects: gastrointestinal injuries, complications, possible threat to the patient’s health or life.
Debridat
Risk of presence of a foreign body in the medicinal product Debridat (Trimebutinum), 7.87 mg/g, granules for oral suspension. Potential effects: mechanical damage, complications, irritation of the gastrointestinal tract.
Debridat
Risk of the presence of a foreign body in the medicinal product, possibly due to a potential quality defect. Potential effects: mechanical damage to the gastrointestinal tract, complications, need for medical intervention.
Debridat
Risk of a potential quality defect consisting in the presence of a foreign body in the product. Potential effects: mechanical injuries, gastrointestinal complications, risk to health or life.
Debridat
Risk of the presence of a foreign body in the medicinal product Debridat (Trimebutinum), 7.87 mg/g, granules for oral suspension, which may cause gastrointestinal damage or other mechanical complications during use. Potential effects: mechanical injuries, complications, risk to health or life.
Apra-swift
A printing inconsistency in the dose on one side of the outer packaging was found (15 mg stated incorrectly, it should be 30 mg). Potential effects: improper dosing, lack of treatment efficacy or adverse effects.
Debridat
Risk of presence of a foreign body in the medicinal product Debridat (Trimebutinum), 7.87 mg/g, granules for oral suspension, which may expose the patient to mechanical damage of the gastrointestinal tract or other complications during use. Potential effects: injuries, complications, health risk.
Raniberl Max
Contamination of the active substance ranitidine with N-nitrosodimethylamine (NDMA) was detected, causing the batches to be deemed non-compliant with quality requirements and potentially hazardous to patients’ health or life. Potential effects: carcinogenic action, organ damage, general poisoning.
Lakcid forte
The test showed that the product sample does not comply with the specification regarding the CFU count of lactic acid bacteria (Lactobacillus rhamnosus), which may mean a lower content of live probiotic bacteria than declared. Potential effects: lack of treatment efficacy, possible worsening of symptoms, delay of therapy.
Lakcid forte
It was found that the product sample does not comply with the specification regarding the number of lactic acid bacteria CFU, which may lead to reduced therapeutic effectiveness of the probiotic preparation. Potential effects: reduced treatment effectiveness, lack of the expected probiotic effect.
Flavamed
A possible increased level of impurity E was identified in batches manufactured using glass bottles from one of the suppliers, which constitutes a quality defect of the medicinal product. Potential effects: possible adverse reactions or reduced treatment safety.
NuTRIflex Omega plus
Cases of product discoloration were found, possibly accompanied by phase separation of the emulsion, indicating a quality defect of a solution intended for intravenous infusion. Potential effects: lack of therapeutic efficacy, metabolic disturbances, complications during parenteral nutrition.
NuTRIflex Omega special
Cases of product discoloration were found, possibly accompanied by phase separation of the emulsion, indicating potential instability of the intravenously administered preparation. Potential effects: lack of treatment efficacy, infusion-related complications, adverse reactions.
Flavamed
Tests by the National Medicines Institute confirmed that the sample of Flavamed batch 82014 did not meet purity specification requirements due to an exceeded level of impurity E, which makes a potential health risk for patients plausible. Potential effects: possible adverse reactions, complications, reduced treatment safety.
Ranimax Teva
In connection with information from the Rapid Alert system on detection of N-nitrosodimethylamine (NDMA) contamination in products containing ranitidine and the substantiated potential risk to patients’ health or life. Potential effects: long-term exposure to NDMA, possible carcinogenic action and other serious toxic effects.
Ranigast Max
Contamination of the active substance ranitidine with N-nitrosodimethylamine (NDMA) was found in batches of the medicinal product Ranigast Max, meaning the quality requirements are not met. Potential effects: possible toxic effects, including long-term health risks.
Ranigast Fast
contamination with N-nitrosodimethylamine (NDMA) in the active substance Ranitidinum used to manufacture the concerned batches of Ranigast Fast. Potential effects: possible carcinogenic effects and other adverse effects related to toxic contamination.
Ranigast
The presence of N-nitrosodimethylamine (NDMA) contamination was found in the active substance ranitidine used to manufacture the Ranigast 150 mg, film-coated tablet batches, which constitutes a quality defect of the medicinal product. Potential effects: increased risk of carcinogenic effects and toxic liver damage.
Ranigast
The presence of N-nitrosodimethylamine (NDMA) contamination was confirmed in the active substance ranitidine used to manufacture batches of Ranigast 0.5 mg/ml, solution for infusion, which may pose a potential risk to patients' health. Potencjalne skutki: increased risk of adverse effects, including possible carcinogenic action with long-term exposure.
Ranigast Pro
Contamination of the active substance Ranitidinum with N-nitrosodimethylamine (NDMA) was detected, representing a quality defect of the product and potentially endangering patients’ health or life. Potential effects: poisoning, carcinogenic effects, serious health complications.
Clopidogrel Genoptim
A result outside the quality specification was found for the parameters: clopidogrel-related substances — impurity A and enantiomeric purity — impurity C, which may affect the safety and efficacy of the medicine. Potential effects: lack of treatment efficacy or adverse reactions.
Mitomycin C Kyowa
Due to identified deviations in the manufacturing process of the active substance, it cannot be ensured that the medicinal products made from it meet sterility specification requirements. The authority points to a potential direct threat to patients’ health or life. Potential effects: infection, severe post-injection complications, risk to health or life.
Mitomycin C Kyowa
Deviations were identified in the manufacturing process of the active substance, so it cannot be ensured that the products meet sterility specification requirements, which may pose a real threat to patients' health or life. Potential effects: infection, complications after intravenous administration, life‑threatening conditions.
TRANXENE 20
A quality defect was identified: potential presence of visible particles in solvent ampoules of a product intended for preparation of an injectable solution. Potential effects: complications after intravenous administration, embolism, inflammatory reactions, lack of treatment safety.
AVONEX
Suspected quality defect of the immediate packaging of the specified batches, which may result in loss of tightness and a potential risk to patients’ health or life. Potential effects: infections, complications after administration of a non-sterile drug, lack of treatment efficacy.
RANIC
Contamination of the medicinal product with trace amounts of N-nitrosodimethylamine (NDMA) in the ranitidine-containing solution for injection. Potential effects: carcinogenic and toxic effects, possible health risk.
PALIN
The European Medicines Agency decision concerned serious adverse reactions of some quinolone and fluoroquinolone antibiotics; the benefit-risk balance of products containing pipemidic acid is no longer favorable. Potential effects: serious adverse reactions, complications, risk to health or life.
RANITYDYNA AUROVITAS
Exceedance of the acceptable limit of N-nitrosodimethylamine (NDMA) contamination was detected and confirmed in products containing Ranitidinum, creating a real, high probability of a threat to patients’ health or life. Potential effects: chronic exposure, carcinogenic effects, liver damage, general poisoning of the body.
MEGAPAR FORTE
An error in the leaflet incorrectly specifies the maximum dose, which may lead to overdose and poses a real risk to patients’ health or life. Potential effects: paracetamol poisoning, liver damage, serious complications, life‑threatening condition.
APHTIN
Non-compliant product odor and a decrease in active substance content were found, not meeting quality specifications. Potential effects: lack of treatment efficacy, possible adverse effects related to product degradation.
SYMBELLA
The product does not meet specification requirements for the amount of ethinylestradiol released within 15 minutes, which may affect contraceptive efficacy. Potential effects: reduced effectiveness, risk of unplanned pregnancy.
BICAVERA Z 1,5% GLUKOZĄ I WAPNIEM 1,25 MMOL/L
Potential quality defect of the primary packaging, which may affect the safety and quality of the peritoneal dialysis solution. Potential effects: complications during dialysis, infections, lack of treatment efficacy.
IBUFEN DLA DZIECI FORTE O SMAKU TRUSKAWKOWYM
A quality defect consisting of an out-of-specification result for the ibuprofen content parameter in the medicinal product Ibufen for children Forte, strawberry flavour. Potential effects: lack of treatment efficacy or overdose leading to adverse reactions.
BENZACNE
A defective internal lacquer coating was found on the inner surface of the primary packaging (tube) used for packing the medicinal product, creating a substantiated potential risk to patients’ health or life. Potential effects: health complications, possible loss of medicine quality or safety.
ZOLAXA RAPID
A quality defect was found: an out-of-specification result for the active substance content per tablet, which may mean an incorrect dose of the medicine for the patient. Potential effects: lack of treatment efficacy or increased adverse effects.
PULNEO
It was determined that the benefit‑risk balance of medicinal products containing fenspiride, including Pulneo, is not favorable, which may pose a real threat to patients’ health or life. Potential effects: serious adverse reactions, threat to health or life.
FOSIDAL O SMAKU POMARAŃCZOWYM
It was found that the risk of using products containing fenspiride is disproportionate to their therapeutic effect, with a potential threat to patients’ health or life. Potential effects: serious adverse reactions, complications and life‑threatening events.
FOSIDAL O SMAKU MALINOWYM
A risk of use disproportionate to the therapeutic effect of the product containing fenspiride was identified, which may pose a real and highly probable threat to patients’ health or life. Potential effects: treatment complications, serious adverse reactions, threat to health or life.
EURESPAL
It was found that the benefit-risk balance of products containing fenspiride is unfavorable, meaning a risk of use disproportionate to the therapeutic effect and a potential threat to patients’ health or life. Potential effects: serious adverse reactions, life-threatening events, lack of safe therapy.
EURESPAL
A risk of use disproportionate to the therapeutic effect of the medicinal product Eurespal was identified, which may pose a direct threat to patients’ health or life. Potential effects: serious adverse reactions, threat to patients’ health or life.
PULNEO O SMAKU COLI
It was found that the benefit–risk ratio of medicinal products containing fenspiride is not favourable, and therefore withdrawal of marketing authorisations for these products was recommended. Potential effects: lack of adequate treatment efficacy, possible serious adverse reactions.
PULNEO
A use-related risk disproportionate to the therapeutic effect was identified for medicinal products containing fenspiride, with the benefit–risk balance considered unfavorable, which may pose a real threat to patients’ health or life. Potential effects: lack of treatment efficacy, complications, and risk to patient health or life.
FENSPOGAL
A risk of use disproportionate to the therapeutic effect was identified for products containing fenspiride, considered by PRAC and CMDh significant enough to recommend withdrawal of marketing authorizations. Potential effects: serious adverse reactions, risk to health or life, unacceptable safety profile.
EURESPAL
A risk of use disproportionate to the therapeutic effect was identified for medicinal products containing fenspiride, meaning an unfavorable benefit–risk balance and potential health threat to patients. Potential effects: lack of treatment efficacy, complications from adverse reactions, risk to health or life.
EURESPAL
No information in the text about a specific hazard, type of product defect, contamination, composition, or health risk for patients. Potential effects: impossible to assess risk, possible lack of efficacy or other undefined product-related issues.
EUREFIN
A risk of use of the medicinal product Eurefin disproportionate to its therapeutic effect was identified, meaning that the benefit–risk balance of medicines containing fenspiride is not favourable. Potential effects: serious adverse reactions, unacceptable safety profile, possible threat to patients’ health or life.
Elofen
Determination of a risk of use disproportionate to the therapeutic effect of the medicinal product Elofen, with a significant probability of harm to individuals and a real, highly probable threat to patients’ health or life. Potential effects: serious adverse reactions, complications, threat to health or life, lack of a favorable benefit‑risk balance.
EURESPAL
A risk of using the medicinal product Eurespal disproportionate to its therapeutic effect was identified, which may cause a significant threat to patients’ health or life. Potential effects: treatment complications, lack of efficacy, possible serious adverse reactions.
CURATODERM
A quality defect was found consisting of out-of-specification results for the active substance content parameter during stability testing of the medicinal product Curatoderm. Potential effects: lack of treatment efficacy or abnormal product action.
BDS N
Out-of-specification results were found in archival samples regarding the content of budesonide-related substances, due to exceeded levels of impurities. Potential effects: reduced treatment effectiveness or adverse effects related to the presence of impurities.
THIOGAMMA
A quality defect was found consisting in non-compliance of the disintegration parameter with the specification, which may mean improper release of the active substance and failure to ensure the established quality of the medicinal product. Potential effects: lack of treatment efficacy or its reduction.
BDS N
Out-of-specification results were found in archival samples regarding the parameter "content of budesonide-related substances", due to exceeded impurity levels. Potential effects: possible adverse reactions, toxicity, or lack of expected therapeutic efficacy.
BDS N
Out-of-specification results were found in archival samples for the parameter of budesonide-related substances content, due to exceeded impurity levels. Potential effects: possible adverse effects, toxicity, or lack of expected drug efficacy.
CLOPIDOGREL GENOPTIM
An incorrect name of the active substance was placed on the unit packaging, which may lead to medication errors and use of an inappropriate medicine or dose. Potential effects: lack of treatment efficacy, therapy complications, possible serious adverse reactions.
BUDIXON NEB
Exceeding the specification limit for the parameter of budesonide-related substances was found for batch 060218 and a probability of exceeding the limit for other in-date batches. Potential effects: lack of treatment efficacy or unpredictable adverse reactions.
BUDIXON NEB
Exceeding of specification limits for the content of budesonide related substances was found for batch 060218, with a probability of exceeding the limit for other batches still within shelf-life. Potential effects: lack of treatment efficacy, unpredictable adverse reactions.
BUDIXON NEB
Exceedance of the specification limit for the content of budesonide related substances was found in one batch and there is a probability of exceeding this limit in other batches of the product. Potential effects: possible lack of efficacy, unpredictable drug action, therapy complications.
BUDIXON NEB
Exceedance of the specification limit for the content of budesonide-related substances was found for one batch and a probability of exceeding this limit for other batches of the product. Potential effects: lack of treatment efficacy or unpredictable adverse reactions.
PŁYN BUROWA
Out-of-specification results were found in the ongoing stability program for parameters: appearance and purity — sulfate content, meaning the medicinal product does not meet established quality requirements. Potential effects: lack of therapeutic efficacy or unforeseen adverse reactions.
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.