Poland drug safety bans and recalls

In late July 2026 Poland’s chief drug regulator, the Główny Inspektorat Farmaceutyczny (GIF), ordered a nationwide withdrawal of Concor 5 mg and Concor Cor 5 mg hypertension tablets after testing identified nitrosamine N‑Nitroso‑Bisoprolol (NBP) above the permissible limit. The contamination was traced to specific batches produced between November 2022 and September 2023 by Merck and to parallel‑imported batches from Bulgaria and Spain, with the auxiliary substance supplier excluded from production. Patients were instructed to stop using the tablets and return them for replacement.

A week later GIF issued a second urgent recall, this time of Adnamil 300 mg allopurinol tablets used for gout and kidney stones. The recall targeted a single batch from Polfarmex S.A. after inspection revealed a white powdery coating, tablet damage, and excessive resistance to crushing, raising concerns about the drug’s release and safety. Distribution of the batch was banned across Poland.

On 31 July 2026 the regulator expanded its actions, prohibiting the introduction of Atorvastatin Medical Valley tablets across all series because coating defects could compromise stability and efficacy, and reaffirming the withdrawal of the contaminated Concor batches. In the same announcement the national sanitary inspection warned of Listeria monocytogenes in a batch of raw sausage, and the Ministry of Health reported that the anti‑export list now covers 288 medicines, about 1.6 % of authorized products.