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Recalled products — current list 2026

Recalls in Poland are issued by GIS (Chief Sanitary Inspector) for food and cosmetics, GIF (Chief Pharmaceutical Inspector) for medicines, and UOKiK for consumer products. The list below brings every alert together in one place and is updated continuously as new recalls are published.

2 162 alerts in the database last update:

Latest recalled products

Recalled product: Ranimax Teva

Ranimax Teva

GIF Critical 29.10.2019

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.

Recalled product: Ranigast Max

Ranigast Max

GIF High 28.10.2019

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.

Recalled product: Ranigast Fast

Ranigast Fast

GIF High 28.10.2019

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.

Recalled product: Ranigast

Ranigast

GIF Critical 28.10.2019

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.

Recalled product: Ranigast

Ranigast

GIF Critical 28.10.2019

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.

Recalled product: Ranigast Pro

Ranigast Pro

GIF Critical 28.10.2019

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.

Recalled product: Clopidogrel Genoptim

Clopidogrel Genoptim

GIF Medium 25.10.2019

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.

Recalled product: Mitomycin C Kyowa

Mitomycin C Kyowa

GIF Critical 25.10.2019

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.

Recalled product: Mitomycin C Kyowa

Mitomycin C Kyowa

GIF Critical 25.10.2019

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.

Recalled product: TRANXENE 20

TRANXENE 20

GIF Critical 23.10.2019

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.

Recalled product: AVONEX

AVONEX

GIF Critical 18.10.2019

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.

Recalled product: RANIC

RANIC

GIF Critical 18.10.2019

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.

Recalled product: PALIN

PALIN

GIF Critical 11.10.2019

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.

Recalled product: RANITYDYNA AUROVITAS

RANITYDYNA AUROVITAS

GIF Critical 11.10.2019

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.

Recalled product: MEGAPAR FORTE

MEGAPAR FORTE

GIF Critical 02.10.2019

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.

Recalled product: APHTIN

APHTIN

GIF Medium 26.09.2019

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.

Recalled product: SYMBELLA

SYMBELLA

GIF Critical 25.09.2019

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.

Recalled product: BICAVERA Z 1,5% GLUKOZĄ I WAPNIEM 1,25 MMOL/L

BICAVERA Z 1,5% GLUKOZĄ I WAPNIEM 1,25 MMOL/L

GIF Critical 16.09.2019

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.

Recalled product: IBUFEN DLA DZIECI FORTE O SMAKU TRUSKAWKOWYM

IBUFEN DLA DZIECI FORTE O SMAKU TRUSKAWKOWYM

GIF Critical 10.09.2019

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.

Recalled product: BENZACNE

BENZACNE

GIF Medium 30.08.2019

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.

Recalled product: ZOLAXA RAPID

ZOLAXA RAPID

GIF High 29.08.2019

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.

Recalled product: PULNEO

PULNEO

GIF Critical 22.08.2019

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.

Recalled product: FOSIDAL O SMAKU POMARAŃCZOWYM

FOSIDAL O SMAKU POMARAŃCZOWYM

GIF Critical 22.08.2019

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.

Recalled product: FOSIDAL O SMAKU MALINOWYM

FOSIDAL O SMAKU MALINOWYM

GIF Critical 22.08.2019

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.

Recalled product: EURESPAL

EURESPAL

GIF Critical 22.08.2019

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.

Recalled product: EURESPAL

EURESPAL

GIF Critical 22.08.2019

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.

Recalled product: PULNEO O SMAKU COLI

PULNEO O SMAKU COLI

GIF Critical 22.08.2019

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.

Recalled product: PULNEO

PULNEO

GIF Critical 22.08.2019

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.

Recalled product: FENSPOGAL

FENSPOGAL

GIF Critical 22.08.2019

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.

Recalled product: EURESPAL

EURESPAL

GIF Critical 22.08.2019

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.

Recalled product: EURESPAL

EURESPAL

GIF Low 22.08.2019

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.

Recalled product: EUREFIN

EUREFIN

GIF Critical 22.08.2019

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.

Recalled product: Elofen

Elofen

GIF Critical 22.08.2019

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.

Recalled product: EURESPAL

EURESPAL

GIF Critical 22.08.2019

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.

Recalled product: CURATODERM

CURATODERM

GIF Critical 20.08.2019

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.

Recalled product: BDS N

BDS N

GIF Medium 20.08.2019

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.

Recalled product: THIOGAMMA

THIOGAMMA

GIF Medium 13.08.2019

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.

Recalled product: BDS N

BDS N

GIF Critical 07.08.2019

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.

Recalled product: BDS N

BDS N

GIF Critical 07.08.2019

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.

Recalled product: CLOPIDOGREL GENOPTIM

CLOPIDOGREL GENOPTIM

GIF High 02.08.2019

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.

Recalled product: BUDIXON NEB

BUDIXON NEB

GIF Medium 01.08.2019

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.

Recalled product: BUDIXON NEB

BUDIXON NEB

GIF Medium 01.08.2019

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.

Recalled product: BUDIXON NEB

BUDIXON NEB

GIF Critical 01.08.2019

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.

Recalled product: BUDIXON NEB

BUDIXON NEB

GIF Medium 01.08.2019

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.

Recalled product: PŁYN BUROWA

PŁYN BUROWA

GIF Medium 24.07.2019

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.

Recalled product: POLYVACCINUM MITE

POLYVACCINUM MITE

GIF Critical 17.07.2019

In one bottle of the medicinal product batch a solid body floating on the surface of the suspension was found, which poses a potential risk to patients' health. Potential effects: complications after administration, irritation, inflammatory reaction, lack of therapeutic efficacy.

Recalled product: BDS N

BDS N

GIF Medium 17.07.2019

Out-of-specification results were found for the content of related substances of budesonide, due to exceeded impurity levels. Potential effects: lack of treatment efficacy or adverse reactions caused by impurities.

Recalled product: ROZAPROST MONO

ROZAPROST MONO

GIF Low 15.07.2019

No information in the text about the type of hazard, contamination, quality defect or safety issue concerning a specific medicinal product or batch. Potential effects: impossible to assess risk, need to exercise caution until full data are obtained.

Recalled product: ROZAPROST MONO

ROZAPROST MONO

GIF Low 15.07.2019

No information in the text about any specific hazard to the quality, safety, or efficacy of any medicinal product. Potential effects: no effects can be determined based on the available information.

Recalled product: BENODIL

BENODIL

GIF Critical 10.07.2019

Risk of not meeting finished product specification with respect to the parameter of related substances content, which may indicate a quality defect of the medicinal product. Potential effects: lack of efficacy or unpredictable adverse reactions.

Recalled product: BENODIL

BENODIL

GIF Medium 10.07.2019

A risk was identified that the finished product may not meet specification requirements regarding the level of related substances, indicating a possible quality defect. Potential effects: possible lack of efficacy or unpredictable adverse reactions.

Recalled product: BUDIXON NEB

BUDIXON NEB

GIF Medium 04.07.2019

Exceeding the specification limit for the parameter of budesonide-related substances content was found, meaning the product does not meet established quality requirements. Potential effects: possible lack of treatment efficacy or adverse reactions.

Recalled product: BDS N

BDS N

GIF Critical 01.07.2019

It was confirmed that the specification limit for the parameter 'content of related substances' was exceeded, due to an increased level of impurities. Potential effects: possible adverse reactions, toxicity, lack of therapeutic efficacy.

Recalled product: BDS N

BDS N

GIF Critical 01.07.2019

The specification limit for the parameter "content of related substances" was exceeded due to increased impurity content, constituting a quality defect of the medicinal product and a potential risk to patients' health. Potential effects: poisoning, adverse reactions, lack of therapeutic efficacy.

Recalled product: ASANIX

ASANIX

GIF High 28.06.2019

A quality defect was found: in the ongoing stability testing program an out-of-specification result was obtained for the parameter of active substance release from the tablet, meaning the drug may not release the correct amount of active ingredient. Potential effects: lack of treatment efficacy or unpredictable drug action.

Recalled product: BENODIL

BENODIL

GIF Medium 27.06.2019

It was found that the specification limit for the related substances content parameter was exceeded, meaning the product does not meet established quality requirements. Potential effects: possible lack of efficacy, unpredictable adverse reactions.

Recalled product: 3% ROZTWÓR KWASU BOROWEGO

3% ROZTWÓR KWASU BOROWEGO

GIF Medium 19.06.2019

A quality defect was found: boric acid content 0.3% instead of the required 2.8–3.2% and a non‑compliant form of the raw material, which may lead to compounding magistral medicines with incorrect strength. Potential effects: lack of treatment efficacy, possible disease complications.

Recalled product: 3% ROZTWÓR KWASU BOROWEGO

3% ROZTWÓR KWASU BOROWEGO

GIF Critical 19.06.2019

A quality defect was found: boric acid content is 0.3% instead of 2.8%-3.2% and the form is non-compliant, which may lead to compounded medicines with incorrect strength and efficacy. Potential effects: lack of therapeutic efficacy, possible disease complications.

Recalled product: 3% ROZTWÓR KWASU BOROWEGO

3% ROZTWÓR KWASU BOROWEGO

GIF High 19.06.2019

A quality defect was found: too low boric acid content (should be 2.8%–3.2%, actual 0.3%) and non‑compliant form, which may lead to preparation of compounded medicines with incorrect strength and effectiveness. Potential effects: lack of drug efficacy, risk of therapy complications.

Recalled product: CALCIUM POLFARMEX (O SMAKU TRUSKAWKOWYM)

CALCIUM POLFARMEX (O SMAKU TRUSKAWKOWYM)

GIF Medium 13.06.2019

A quality defect of the medicinal product was found in the form of an improper smell of the syrup, which may indicate irregularities in the composition or stability of the product. Potential effects: lack of efficacy, possible irritation or other adverse reactions.

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Frequently asked questions

What are GIS alerts?

GIS (Chief Sanitary Inspector) alerts are official warnings about food products that have been recalled from the Polish market due to health hazards like salmonella, listeria, E. coli or foreign objects.

What are GIF alerts?

GIF (Chief Pharmaceutical Inspector) alerts are warnings about pharmaceutical products and medicines that have been recalled due to quality or safety issues.

What are UOKiK alerts?

UOKiK (Office of Competition and Consumer Protection) alerts are warnings about dangerous consumer products in Poland, including toys, electronics and household items that pose safety risks.

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 GIS/GIF 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.

  1. 1

    Do not eat or use the product

    Stop using or consuming it immediately and keep it out of reach of children.

  2. 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.

  3. 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.

  4. 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.