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
Gastrografin
Tests showed the presence of N-nitroso-meglumine contamination exceeding the acceptable daily intake and the temporary LTL limit for contrast agents. N-nitroso-meglumine is regarded as a potentially carcinogenic impurity. Potential effects: increased risk of carcinogenic effects and other complications related to long-term exposure.
Gastrografin
Based on tests of a representative number of batches of the medicinal product manufactured from December 2020 to April 2024, the presence of N-nitroso-meglumine contamination was confirmed, with a content exceeding the acceptable intake (AI) limit of 100 ng/day. N-nitroso-meglumine is considered a potential carcinogenic impurity. Potential effects: increased carcinogenic risk and harm to patient health.
POLIPARIN 25000 IU/5 ml, Heparin sodium, solution for injection and infusion, 25000 IU/5 ml, 5 ml x 1 vial
Reported non‑conformities included “ganglionic thrombosis after administration of the product in several patients”. SMZ analysis confirmed public health hazards and the serious nature of adverse reactions, posing a real risk to patients. Potential effects: thrombosis, vascular complications, risk to health and life.
Hyalgan
The lack of ATD protection on the outer packaging prevents verification of package tampering and full authenticity of the medicine, creating a risk of easy opening of the carton and replacement of the original product with another. Potential effects: medicine falsification, lack of efficacy, complications after injection.
Elenium
A non-compliance of the active substance dissolution parameter was found in stability studies, meaning reduced and delayed drug release and uncertainty regarding the efficacy and safety of the tablets throughout their shelf life. Potential effects: lack of treatment efficacy, disease complications.
Dexapini
Sediment in the form of crystals was found at the bottom of the syrup bottle, not compliant with the quality specification. Failure to determine the cause of crystallization and the risk of disturbed antimicrobial protection and microbiological purity prevent ruling out a risk to patient health. Potential effects: infections, lack of treatment efficacy, health complications.
Korzeń Kozłka
A non‑compliance with quality requirements was found in the parameter of sesquiterpene acid content, which may affect the effectiveness of the product, even though no direct threat to the patient’s life or health was stated. Potential effects: lack of therapeutic efficacy.
Vitamina C Synteza
The identified non-compliance in the form of brown spots and discoloration on the capsule surface may affect the safety of medicinal product use; a risk to human health and life cannot be excluded. Potential effects: possible health risk, potential complications related to inadequate medicine quality.
VBLAAST 10
The presence of particles visible to the naked eye of unidentified origin was found in the solution for injection, which creates a real danger of such particles entering the patient’s bloodstream and may lead to unpredictable, negative health effects. Potential effects: embolic complications, vascular damage, severe systemic reactions, life-threatening conditions.
Apap Extra
A risk of contamination of tablets with fragments of a damaged discharge valve gasket of the granulator was identified; the presence of a foreign body in a tablet may affect safety of use and pose a threat to human health and life. Potential effects: mechanical injuries of the gastrointestinal tract, choking, complications requiring medical intervention.
Angeliq
It was found that an outdated version of the patient leaflet was included with batch KT0SLCS, so information on use, safety and adverse reactions does not meet current requirements. Potential effects: improper use of the medicine, lack of efficacy, increased risk of adverse reactions or complications.
Triacyt MR
The incorrect leaflet attached to batch 250202 does not contain updated information on the possibility of severe cutaneous adverse reactions during trimetazidine dihydrochloride use, which may affect treatment safety. Potential effects: severe skin reactions, complications, improper use of the medicine.
Elenium
The identified non-compliance in the active substance release rate affects the product’s quality and may impact its efficacy and safety. The acceptance criterion for the minimum amount of released active substance was not met. Potential effects: lack of treatment efficacy, deterioration of health, complications related to insufficient drug action.
Elenium
The identified non‑compliance in the active substance dissolution parameter affects product quality and may impact the effectiveness and safety of its use; a risk to human health cannot be excluded. Potential effects: lack of therapeutic effect, adverse reactions, health risk.
Elenium
A non-compliance was found in the parameter of the degree of active substance release, which affects product quality and may impact the effectiveness and safety of its use; a risk to human health cannot be excluded. Potential effects: lack of treatment efficacy, worsening of symptoms, unpredictable drug action.
Soliris
Risk of confusion among medical staff due to information on the route and method of administration being given in Slovak and Czech on the vial. Potencjalne skutki: incorrect administration of the drug, treatment complications, risk to patient health.
Bupivacaine and Epinephrine, Bupivacaine-Epinephrine 0,5%,
The product is a solution for injection; a change in colour from clear to opalescent, brown or yellow may indicate drug degradation; a discoloured product must not be used and must be discarded. Potential effects: lack of efficacy, adverse reactions or complications after administration of a solution of inadequate quality.
Liv 52
a medicinal product whose quality cannot be properly verified due to the company’s failure to update the documentation that serves as the reference point for assessing the product’s quality. Potential effects: lack of efficacy, unpredictable adverse reactions.
Pectosol
Leakage from unit packs caused by incompatibility of the bottle with the cap and an out-of-specification result for the “content in the package” parameter were found, which may affect safety of use until the end of shelf life. Potential effects: lack of treatment efficacy, possible irritation or complications if the product becomes contaminated.
Hemkortin-HC
The non-compliance in the parameter “zinc sulfate monohydrate content” indicated by OMCL may affect product quality and safety of use, and therefore a risk to human health cannot be excluded. Potential effects: lack of treatment efficacy, possible disease complications, skin reactions.
Septogard Plus
Exceeding the upper specification limit for “Related substances. Unspecified Cetylpyridinium impurity” was found, which may affect product quality and safety of use and may pose a risk to human health. Potential effects: impaired drug efficacy, adverse reactions, complications.
Cefazolin TZF
The presence of brown liquid was found in some vials instead of white or almost white powder, indicating a serious quality defect that may affect the product’s safety and efficacy. Potential effects: lack of treatment efficacy, infections, severe complications after intravenous administration.
Monover
A visible large piece of glass of about 1 cm moving inside the vial and glass particles on the walls and neck of the vial of a product administered intravenously were detected. Potential effects: damage to blood vessels, embolism, thrombotic complications, severe systemic complications, life‑threatening conditions.
Osporil
The National Medicines Institute found, in batch ZD033, particles visible to the naked eye in two of twenty inspected vials of the infusion solution. Potential effects: embolism, inflammatory reactions, complications after intravenous administration.
Liść Senesu
Fragments of plastics were detected in the tested sample of the batch and the product failed the requirement for the parameter “presence of mould, live and dead pests and their residues.” Potential effects: mechanical damage, irritation of the gastrointestinal tract, complications requiring medical intervention.
Polibiotic
The non-compliance in the parameters of dosage form and properties or water content may affect the quality of this product and the safety of its use, and therefore a risk to human health resulting from leaving these batches on the market cannot be excluded. Potential effects: reduced treatment effectiveness, possible skin irritation or other adverse skin reactions.
Paracetamol Hasco
Non-compliance was found regarding non-uniform impurity content in the active substance used to manufacture the product batches, which may affect product quality and the safety of its use, posing a potential risk to human health. Potential effects: possible health risk, lack of efficacy or adverse reactions.
Gripblocker Express
Non-uniform impurity content was found in the active substance used to manufacture the product batches, which may affect product quality and safety of use, and a risk to human health cannot be excluded. Potential effects: possible adverse reactions, poisoning, or other health complications.
Paracetamol Hasco
A non-compliance was found – non-uniform impurity content in the active substance used to manufacture the product batches, which may affect product quality and safety of use. Potential effects: possible adverse reactions, toxicity or reduced treatment safety.
Pulmopect
Non-uniform syrup consistency and presence of a gel-like floating substance not dissolving on shaking; out-of-specification result for microbiological purity. Potential effects: infections, risk of infection.
Enema
Detected sediment as solid white flakes and turbidity of the solution, inconsistent with specification (product should be clear and free of mechanical impurities). Potential effects: irritation, infection risk, reduced efficacy.
Adrimax
Localized turbidity of the Adrimax syrup solution detected in archived packages, indicating non-conforming appearance and potential loss of quality. Potential effects: poisoning, lack of efficacy, adverse reactions.
Hydroxyzinum Hasco
An increase of an unknown impurity was detected in the 'other single' parameter for hydroxyzine hydrochloride after a production pH-meter failure, resulting in non-compliance with quality specifications. Potential effects: unknown toxic effects, adverse reactions, reduced medicine quality.
Sugammadex Reig Jofre
The presence of visible silicone particles in the product solution was found; the safety report indicates that potential risk to patients from injection of these particles cannot be excluded. Potential effects: vascular complications, inflammatory reactions, emboli, other injection-related complications.
Atofab
Out-of-specification results for atomoxetine content and non-uniform capsule mass caused by manufacturing defects and changed API particle properties. Potential effects: reduced efficacy of the medicine.
Atofab
Results out of specification (OOS) for atomoxetine content and non-uniformity of capsule mass in identified batches. Potential effects: reduced therapeutic efficacy.
Corhydron 25
A quality defect was identified consisting of an out-of-specification result for free hydrocortisone content, with this exceedance expected to increase until the end of the shelf-life of batch 110021. Potential effects: reduced efficacy or unpredictable action of this life-saving emergency medicine.
Faringan
non-compliance was found consisting in exceeding the lower limit of benzocaine content, exceeding the permissible limit of benzocaine-related substances (single unknown impurity and total impurities), and crumbling of tablets after abrasion resistance testing. Potential effects: lack of treatment efficacy, unknown risk from impurities, possible adverse effects.
Symibace
An exceedance of the specification limit for impurity B was found, which according to the authority represents a real and probable risk to human health. Potential effects: poisoning, complications, lack of treatment safety.
Vabysmo
Cracked blisters with needles with a transfer filter were identified in product packs, so sterility of the needles and the solution for injection is not ensured; the defect was classified as Class I, potentially life‑threatening or posing a serious health risk. Potential effects: severe intraocular infections, ophthalmic complications, sepsis, life‑threatening condition.
Eptifab
Incorrect information in the leaflet was found: swapped dosing instructions for patients with normal and impaired renal function, which may lead to improper dosing of the injection solution and direct, serious health consequences. Potential effects: poisoning, severe bleeding complications, lack of treatment efficacy, life‑threatening events.
Gripblocker Express
The quality defect consists of cracking of the soft gelatin capsule seams and leakage of the filling into the blister pocket, creating a real risk to patients’ health due to the possibility of receiving an incomplete dose and lack of treatment effectiveness. Potential effects: lack of treatment efficacy, possible complications of the underlying disease.
Konaten
For some batches reference samples showed out-of-specification atomoxetine content below the lower limit, and for one batch also non-compliant capsule mass uniformity. Potential effects: reduced treatment efficacy, risk of lack of therapeutic effect.
Konaten
Out-of-specification (OOS) results were found for atomoxetine content, below the lower specification limit, and in one batch also non-compliance in the mass uniformity parameter. The risk assessment points mainly to a possibility of reduced treatment effectiveness. Potential effects: absence or reduction of therapeutic efficacy.
Konaten
Out-of-specification (OOS) results were found for atomoxetine content below the lower limit and, for one batch, non-compliant capsule mass uniformity, leading to a reduced dose of the medicine. Potential effects: reduced treatment efficacy, worsening of disease symptoms.
Konaten
Out-of-specification results were found in reference samples for atomoxetine content (outside the 95.0–105.0% range) and, in one case, for capsule mass, indicating variable active substance dosage. Potential effects: reduced treatment effectiveness or increased adverse reactions.
Maść szałwiowa
The lack of a correct authorization number on the packaging makes it impossible to verify if the product may be marketed in Poland and raises doubts about its authenticity. This situation may mislead users and poses a threat to public health. Potential effects: incorrect use of the medicine, lack of treatment efficacy, possible health complications.
Eptifab
An incorrect dosing regimen for the medicinal product in solution for injection form, resulting from erroneous leaflet data, may cause direct adverse health consequences for patients, posing a real risk to health and potentially to life. Potential effects: overdose or insufficient efficacy, serious cardiovascular complications, life‑threatening events.
Gripblocker Express
A quality defect was found: cracking of the soft gelatin capsule seam and leakage of the fill into the blister pocket, risking intake of an incomplete dose and lack of therapeutic effectiveness. Potential effects: lack of efficacy, persistence or worsening of symptoms.
Qutiro
In patients after infusion of the product, chills, chest pain and generalized convulsions occurred; blood cultures grew Klebsiella pneumoniae ESBL, and the inspector indicated a real threat to patients’ health or life. Potential effects: severe bloodstream infections, septic shock, life‑threatening conditions.
Palifren Long
This product does not meet the specified quality requirements due to a negative test result for paliperidone palmitate content and particle size analysis. Potential effects: lack of therapeutic efficacy or adverse reactions after parenteral administration.
Oekolp forte
Exceeding the established limit of an unknown impurity was found in batch 23000333, making it impossible to assess safety of use. The authority indicated a real risk to patients’ health and potentially life. Potential effects: poisoning, serious adverse reactions, life‑threatening events.
Egoropal
It was found that the product does not meet quality requirements due to a failed particle size analysis in the injectable suspension. Potential effects: possible altered drug release, lack of efficacy or unpredictable adverse reactions.
Omegaflex special
An improperly made seal of the outer bag allowed air and oxygen to enter, which could change the properties of the lipid emulsion and poses a real risk to patients’ health and life. Potential effects: complications during infusion, lack of treatment efficacy, adverse reactions.
ACC classic
The presence of solid particles from the sealing insert in the medicinal product in the form of an oral solution creates a high probability of swallowing them, which, depending on the size and shape of the particles, may lead to unpredictable, direct, negative health effects, potentially life‑threatening. Potential effects: irritation of the gastrointestinal tract, mechanical injuries, complications endangering health or life.
Auroverin MR
It was found that the batch does not meet quality requirements due to a negative test result for the mebeverine hydrochloride release parameter, which may lead to improper release and reduced therapeutic efficacy. Potential effects: lack of efficacy, worsening of disease symptoms.
Levosimendan Kabi
Testing by NIL showed that the product does not meet quality specification requirements regarding contamination with particles visible to the naked eye; in 9 of 20 tested vials such particles were found. Potential effects: complications after intravenous infusion, embolism, inflammation, local or systemic reactions.
Misintu
In the prepared solution for injection, visible insoluble particles of unknown nature and origin were detected, which may enter the patient’s bloodstream and cause unpredictable negative health effects. Potential effects: embolic complications, vascular damage, severe systemic reactions, life-threatening conditions.
Vblaast 10
Visible, unidentified crystals were found in the medicinal product in the form of an injection solution, creating a real danger of crystals entering the patient’s bloodstream and causing serious, unpredictable health consequences. Potential effects: thrombotic complications, vascular damage, embolism, severe systemic complications.
Cytostin
In the medicinal product in the form of a solution for injection, crystals of unidentified origin were found, creating a real danger of administering an incorrect active substance dose or of crystals entering the patient’s bloodstream. Potential effects: lack of treatment efficacy, serious vascular complications, life‑threatening events.
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.