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
Tirosint Sol
Due to the reduced content of the active substance found in these batches, a risk to patient health arising from decreased drug effectiveness cannot be excluded. Potential effects: reduced treatment efficacy, possible worsening of thyroid disease symptoms.
Tirosint Sol
Due to the reduced content of the active substance in the specified batches, the risk to patient health from decreased medicinal efficacy cannot be excluded. Potential effects: ineffective treatment of thyroid disorders, worsening of hypothyroidism symptoms, cardiovascular complications in susceptible patients.
Tirosint Sol
Due to the reduced active substance content found in the above-mentioned batches, the risk to patient health resulting from decreased drug efficacy cannot be excluded. Potential effects: reduced effectiveness of hypothyroidism treatment, worsening of disease symptoms.
Tirosint Sol
Due to the reduced content of the active substance in these batches, a risk to patient health from decreased therapeutic efficacy cannot be excluded. Potential effects: lack of treatment efficacy, worsening of health condition.
Tirosint Sol
Reduced content of the active substance – levothyroxine sodium – was found in the listed batches, which may lead to decreased effectiveness of the medicine and a health risk for the patient. Potential effects: reduced efficacy of hypothyroidism treatment, deterioration of health, recurrence of disease symptoms.
Tirosint Sol
Due to the reduced content of the active substance found in these batches, a health risk for the patient resulting from decreased efficacy of the medicine cannot be excluded. Potential effects: reduced effectiveness of hypothyroidism treatment, worsening of health status, possible complications.
Tirosint Sol
Due to the reduced content of the active substance found in these batches, the risk to patient health resulting from decreased effectiveness of the medicine cannot be ruled out. Potential effects: ineffective treatment of hypothyroidism, worsening of disease symptoms, health complications.
Tirosint Sol
Due to the reduced content of the active substance in the listed batches, the risk to patient health resulting from decreased effectiveness of the medicine cannot be excluded. Potential effects: ineffective treatment, exacerbation of thyroid disease, hormonal complications.
Tirosint Sol
Due to the reduced content of the active substance in these batches, the risk to patient health resulting from decreased effectiveness of the medicine cannot be excluded. Potential effects: reduced effectiveness of thyroid hormone therapy, possible worsening of hypothyroidism symptoms.
MORFİN HİDROKLORÜR Osel 0.01 g/1 ml
Lack of efficient and safe opening of ampoules, irregular breaking, injuries to staff and glass crumbling that may enter the ampoule interior and pose a risk to patients. Potential effects: cuts, contamination of the solution with glass, complications after intravenous administration.
ADRENALIN OSEL (Adrenaline), 1 mg/1 mL IM/IV/SC Solution for Injection, Ampułka a 1 mg/ml,
Based on the collected data there is a risk to patients’ health and life due to the inability to use this life‑saving medicine and the possibility of administering a solution contaminated with glass. Potential effects: life‑threatening complications, tissue damage, acute systemic reactions.
ADRENALIN OSEL 1 mg/1 mL IM/IV/SC Solution for Injection
Breaking of the ampoule and inability to open the medicine normally, creating uncertainty whether glass fragments entered the interior and contaminated the solution, posing a threat to the patient’s health and life. Potential effects: life‑threatening complications after injection, tissue damage, lack of effective treatment.
Tirosint Sol
Due to the reduced active substance content found in the above-mentioned batches, a risk to patient health from decreased efficacy of the medicine cannot be excluded. Potential effects: lack of treatment effectiveness, worsening disease control, possible complications of thyroid disorders.
Tirosint Sol
A reduced content of the active substance (levothyroxine) was found in five batches, with out-of-specification results and levels below the established limit, which may lead to decreased drug effectiveness and health risk for patients. Potential effects: reduced efficacy of hypothyroidism treatment, possible worsening of disease symptoms.
Tirosint Sol
Due to the reduced content of the active substance found in the above-mentioned batches, a risk to patient health arising from decreased effectiveness of the medicine cannot be ruled out. Potential effects: lack of treatment efficacy, worsening of disease symptoms.
Tirosint Sol
A decrease in active substance content below the limit and out-of-specification results for levothyroxine content were found, which may lead to reduced effectiveness of the medicine, and a risk to patient health cannot be excluded. Potential effects: reduced treatment effectiveness, worsening of disease symptoms, possible complications resulting from hypothyroidism.
Tirosint Sol
Due to the reduced active substance content found in these batches, a risk to patient health from decreased medicinal efficacy cannot be excluded. Potential effects: reduced treatment efficacy, disease worsening, complications related to insufficient therapy.
Diprophos
A possible occurrence of brown particles with a metallic appearance, identified as stainless steel particles, was found in the suspension for injection. Potential effects: local inflammatory reactions, hypersensitivity, complications after injection of foreign bodies.
Bupicain
The information leaflet for Bupicain contains incorrect data on the possibility of intravenous and intra-arterial administration of the medicine, which is associated with a threat to public health. Potential effects: incorrect administration, severe complications, life-threatening events.
Febrisan
An out-of-specification result was found in stability testing: at 12 months the content limits for paracetamol and ascorbic acid were exceeded; it is uncertain whether the rest of the batch meets quality requirements for active substance content. Potential effects: reduced treatment efficacy or increased adverse effects.
Allergovit
Because there is a risk of misleading medical staff and, consequently, the patient receiving too high a dose of the drug, which may result in a threat to patients’ life and health. Potential effects: life‑threatening reactions, severe allergic reactions, serious complications of therapy.
Bupivacaine Hydrochloride in Dextrose Injection USP
The defective ampoule may crumble, creating a risk of glass particles entering the anaesthetic solution administered to the patient and of being unable to use the medicine during surgery. Potential effects: tissue damage from glass, surgical complications, life-threatening risk, lack of effective anaesthesia.
Allergovit
Incorrect labeling of vials (concentration A-1000 TU/ml labeled as B-10,000 TU/ml) may mislead medical staff and result in administering too high a dose, endangering patients’ life and health. Potential effects: overdose, severe allergic reactions, serious complications, life-threatening conditions.
Bisoratio ASA
An out-of-specification result was found in stability testing for the parameter bisoprolol fumarate related substances: another single impurity. The probability of adverse reactions after exposure to the product cannot be excluded. Potential effects: possible adverse reactions, including toxic symptoms or reduced treatment efficacy.
Rivanol 0,1%
An out-of-specification pH value was detected, which may affect the antibacterial activity of ethacridine. A defective series of glass bottles is the probable cause, and pH changes until expiry are unpredictable. Potential effects: lack of treatment efficacy, possible complications of infections.
Cernevit
An abnormal color of the solution after preparation was found, which may result from leaks caused by scratches on vial necks and lead to increased organic impurities or degradation products exceeding toxicological qualifications. Potential effects: toxic drug effects, parenteral complications, risk to patient health.
Tobramycin B. Braun
It showed an out-of-specification result for the solution colour parameter. The product risk was assessed as RAS class II. Potential effects: possible reduced medicinal product quality, risk of treatment inefficacy or adverse reactions.
Mupina
detection during stability studies of out-of-specification results regarding an unknown impurity… it cannot be ruled out that keeping this product on the market may pose a risk to patient health. Potential effects: unknown adverse reactions, possible risk to patients’ health.
Menaright Forte, Phytomenadion Injection 2mg/0,2 ml
The glass container shatters when opened, leaving glass fragments in the fingers and inside the ampoule, and differences in the solution volume in ampoules were found. Potential effects: injuries, glass foreign bodies, complications after injection, incorrect drug dose, life‑threatening events.
Heviran
A quality defect was found consisting in placing, in some packs of Heviran 400 mg film-coated tablets, a package leaflet in Lithuanian intended for Furosemid Polpharma 40 mg tablets. Potential effects: improper use of the medicine, lack of correct information on dosage, adverse reactions and precautions.
Vitaminum C Teva
A result outside specification limits was found for the parameter particles visible to the naked eye in an intramuscular or intravenous injection solution, which may pose a direct risk to patients’ health or life. Potential effects: embolism, inflammatory reactions, circulatory complications.
Amiodaron Hameln
Increased crystallization of the product was found in the concentrate for solution for injection or infusion, which may affect the safety and efficacy of intravenous administration. Potential effects: vascular embolism, lack of treatment efficacy, intravenous complications.
Tadalafil Aristo
It cannot be excluded that keeping this medicinal product on the market may pose a risk to patient health, due to identified non-compliances with Good Manufacturing Practice at one manufacturer and the possibility of a quality defect. Potential effects: risk to patient health, possible lack of efficacy or other treatment complications.
Tadalafil Aristo
Non-compliance with Good Manufacturing Practice was found at one of the manufacturers, resulting in suspension of the GMP certificate, so it cannot be excluded that keeping the product on the market may pose a risk to patient health. Potential effects: possible risk to patient health, including lack of treatment efficacy or unpredictable adverse effects.
Structum
Out-of-specification results were found for the TAMC parameter (total aerobic microbial count) and the presence or probability of occurrence of Bacillus cereus was demonstrated. Potential effects: bacterial infection, gastrointestinal symptoms, possible intoxication.
Angusta
Given that the cause of the out-of-specification result for an unknown impurity and its impact on the product quality and safety of use are currently unknown, it cannot be ruled out that keeping this product on the market may pose a threat to patient health. Potential effects: threat to patient health.
Lactulose-MIP
A risk of microbiological contamination of the active substance used to manufacture the medicinal product was reported, creating a potential threat to patients' health. Potential effects: infections, complications, lack of treatment safety.
Lactulose-MIP
A risk of microbiological contamination of the active substance used to produce the syrup was identified, resulting in a quality defect of the product and a potential direct threat to patients’ health or life. Potential effects: infection, complications, health risk.
Hemkortin-HC
An error was found in the printed strength of the active substances on the immediate packaging, affecting some tubes in batch D0222, which may lead to incorrect use of the medicine. Potential effects: improper dosing, risk of adverse reactions or lack of treatment efficacy.
Accupro 40
The letter concerned a request for a decision to withdraw the specified batches of medicinal products from the market due to the presence of contamination (N-nitroso-quinapril) above the permitted daily intake limit. Potential effects: possible carcinogenic effects, organ damage, complications of hypertension therapy.
Accupro 20
the presence of the impurity (N-nitroso-quinapril) above the acceptable daily intake limit. Potential effects: increased risk of toxicity and carcinogenic effects, especially during long-term use.
Accupro 10
detection of contamination (N-nitroso-quinapril) above the acceptable daily intake limit. Potential effects: possible carcinogenic effect and increased risk of adverse reactions.
Accupro 5
due to the detected presence of contamination (N-nitroso-quinapril) above the acceptable daily intake limit. Potential effects: possible carcinogenic or toxic effects and a health risk for patients.
Vigantol
Suspected quality defect of the medicinal product resulting from the use of an excipient linked to a batch with an out-of-specification active substance content, which may lead to incorrect dosing of vitamin D. Potential effects: lack of efficacy or adverse effects related to overdose.
Biotrakson
An out-of-specification result for the endotoxin parameter was found in archival samples of an injectable product, which may pose a real and highly probable risk to patients’ health or life. Potential effects: poisoning, severe systemic reactions, septic complications.
NETSPOT
A quality defect of the NETSPOT product was identified – stability test results showed the content of the active substance DOTATATE close to the lower limit of the specification, meaning that established quality requirements are not met. Potential effects: lack of diagnostic efficacy, risk of delayed disease diagnosis.
GLICERYNA 85 %
Out-of-specification results were found for the sugars parameter in the pharmaceutical raw material GLYCERIN 85%, used for preparing magistral medicines, creating a potential risk to patients' health or life. Potential effects: lack of quality and safety of compounded medicines, possible complications.
Atorvox
An error on the outer packaging (simultaneous strength markings 40 mg and 20 mg) may lead to incorrect dispensing from the pharmacy and improper dosing by patients, which may pose a risk to life or health. Potential effects: improper statin dosing, cardiovascular complications or adverse reactions.
APAP Intense
It was found that the medicinal product sample does not meet the specification in the product documentation regarding the appearance parameter, which constitutes a quality defect. Potential effects: possible reduced treatment efficacy or unpredictable drug action.
Vigantol
An out-of-specification result was found during stability testing regarding the active substance content parameter. Potential effects: lack of efficacy or overdose of vitamin D, possible health disorders.
Memantin NeuroPharma
An out-of-specification result for the dissolution parameter was found during stability studies, meaning the medicine may not release the active substance in line with requirements. Potential effects: reduced treatment efficacy or unpredictable drug action.
Tabex
suspected failure to meet quality requirements regarding the impurity content parameter – for N-formylcytisine impurity, which may pose a potential risk to patients’ health or life. Potential effects: adverse reactions, possible poisoning or other health complications.
Sermion
The reason for the withdrawal is an incorrect expiry date in the 2D code printed on the packaging, which does not match the expiry date entered into the National Medicines Verification System. Potential effects: possible use of the product after its expiry date or incorrect withdrawal, which may result in reduced quality or lack of therapeutic efficacy.
Polopiryna Max Hot
Stability testing confirmed an increased content of salicylic acid in the product, which is a quality defect that may affect its safety of use. Potential effects: irritation, adverse reactions, possible symptoms of salicylate poisoning.
Tabex
The tested sample of Tabex 1.5 mg, film-coated tablets, batch No. 31120, does not meet specification requirements for impurity content (N-formylcitisine level). Potential effects: possible adverse reactions, poisoning, lack of expected therapeutic efficacy.
Elenium
An out-of-specification result was found in the ongoing stability study after 18 months for the parameter: degree of release of the active substance (Chlordiazepoxide). Potential effects: possible lack of therapeutic efficacy, risk of worsening of disease symptoms.
Ikervis
The quality defect consisting in the presence of crystals of the active substance in Ikervis eye drops emulsion may pose a potential risk to patients’ health, especially the risk of irritation and damage to the ocular surface. Potential effects: eye irritation, pain, corneal damage, ophthalmic complications.
Thioealth
Control activities by the Voivodeship Pharmaceutical Inspector confirmed the presence of a piece of glass in one vial of the product, creating a direct risk to patients’ health or life during administration of the solution for injection. Potential effects: tissue damage, embolism, thromboembolic complications, life-threatening conditions.
Aribit
An out-of-specification result was obtained in long-term stability testing for the parameter: aripiprazole active substance content, confirming that the product does not meet quality requirements. Potential effects: lack of treatment efficacy or adverse effects related to an incorrect dose.
Champix
The presence of N-nitroso-varenicline in CHAMPIX was found at levels exceeding the limits set by the CHMP. Potential effects: possible carcinogenic action and other toxic effects.
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.