Recalled Medicines & supplements – Current GIS Alerts 2026
Found 700 recalled products in the Medicines & supplements category. Check batch numbers, shops, and hazard information.
Common hazards in this category
All recalled products
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.
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.
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.
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 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.
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.
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.
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.
What to do if you bought a recalled product?
If you have purchased any of the products listed above, stop using or consuming them immediately. You can return the product to the store where you bought it for a full refund. Keep the receipt if possible, but most stores will accept returns even without one.