Decision made February 17, 2026 affects specific series of Grofibrat 200; patients may be eligible for refunds.
Withdrawal of Grofibrat 200 – Check for series H36032A and expiration date
The withdrawal does not affect all Grofibrat 200 packages, but only one specified in the decision. The entire country has withdrawn this particular series.
This information comes directly from GIF decision No. 10/WC/ZW/2026. If the series number on your package is different, the decision does not apply to it. However, it is worth checking the printing on the box and blister carefully.
Why did GIF withdraw Grofibrat 200? Problem with active substance release
The reason for the withdrawal is an “out-of-specification” (OOS) result in a stability test. Long-term studies showed that the parameter for the release of the active substance does not meet quality requirements.
The drug may release a smaller amount of active substance than the registration documentation provides. GIF directly indicated that lower release of the active substance may affect the effectiveness of therapy and therapeutic decisions made by the physician.
Grofibrat 200 (fenofibrate) – What is this drug and why do seniors 65+ get it for free?
Grofibrat 200 contains fenofibrate – a drug used in the treatment of lipid disorders, especially elevated levels of triglycerides and cholesterol. It is often taken by patients with these conditions.
This is a preparation well known to general practitioners and cardiologists. For many seniors 65+, it is available free of charge as part of the list of reimbursed drugs (List “S”).
Immediate enforcement – must pharmacies withdraw the drug already?
GIF has given the decision immediate enforcement. This means that the series cannot be sold further, wholesalers and pharmacies must withdraw it and it is forbidden to reintroduce it to circulation.
Products that do not meet quality requirements are subject to destruction in accordance with Pharmaceutical Law, unless the body decides otherwise.
Do you have series H36032A at home? How to return the drug and will you get a refund?
If you check the package and see the number H36032A, you should not use this drug without consulting a doctor.
In the case of reimbursed drugs, a refund of costs in the pharmacy for the product covered by the withdrawal is standard. However, the details of the procedure may depend on the refund organization by the responsible entity and wholesalers. It is worth keeping a receipt if available.
Does the withdrawn Grofibrat 200 pose a health risk? GIF indicates real risk
The responsible entity conducted a risk assessment and indicated no reports of adverse effects related to lack of effectiveness. However, GIF recognized that non-compliance with quality requirements constitutes a real threat to the proper effectiveness of treatment.
So it’s not about contamination or toxicity, but about possible reduced effectiveness of therapy.