The Chief Pharmaceutical Inspector has decided to immediately withdraw from the market a batch of the popular drug Grofibrat 200, used in the treatment of lipid disorders. The decision, which was given immediate enforceability status, results from failure to meet quality standards regarding the release of the active substance. The issue primarily concerns seniors, who have recently been receiving this medication free of charge under special reimbursement lists.
Withdrawal with immediate enforceability
On February 17, 2026, GIF ordered the immediate cessation of sales of the drug Grofibrat 200 due to failure to meet release standards of the active substance.
Product quality defect
Stability studies showed a result not meeting specification (OOS), which creates a real risk of lack of therapeutic effects in patients.
Free drug for seniors
The cholesterol product is covered by reimbursement for seniors aged 65+, meaning the withdrawal affects a large group of patients using free treatment.
On February 17, 2026, the Chief Pharmaceutical Inspectorate (GIF) issued decision No. 10/WC/ZW/2026, under which a specific batch of the medicinal product Grofibrat 200 was withdrawn from circulation across the entire country. This preparation, containing the active substance fenofibrate, is commonly used to lower cholesterol and triglyceride levels in the blood. The reason for the officials' radical step was a report from the marketing authorization holder, which detected a quality defect during long-term stability studies. Analyses showed that the release of the active substance did not meet the specification, which in practice may mean reduced therapeutic efficacy of the drug and a real threat to the course of patient treatment. The institution of the Chief Pharmaceutical Inspector was established in Poland in 1998, taking over the tasks of supervising the drug market from the structures of the Ministry of Health, which was intended to ensure greater independence in the quality control of medicinal products.The GIF decision has immediate enforceability, which obliges wholesalers and pharmacies to immediately suspend sales and return the defective batch to the manufacturer. The situation is particularly important for people over 65 years of age, as Grofibrat 200 is on the list of free medicines for seniors (the so-called S list). Patients who have this preparation in their home medicine cabinets should check the batch number on the packaging. The Chief Pharmaceutical Inspector emphasizes that the confirmed quality defect (Out of Specification) constitutes sufficient grounds for product withdrawal, even if an immediate life-threatening risk has not been confirmed. February 17 — A decision for immediate drug withdrawal was issued The withdrawal concerns only a specific product batch, not all Grofibrat packages available in pharmacies. Patients who regularly take this medication are encouraged to consult with a doctor or pharmacist to determine if their package comes from the defective batch. A quality defect prevents further safe distribution, and the marketing authorization holder is obliged to carry out the withdrawal procedure at its own expense. Experts remind that sudden discontinuation of cholesterol treatment should always be consulted with a specialist. Status of Grofibrat 200 Drug: : → ; : →