Poland recalls 25 batches of Olfen MAX gel over NDEA impurity

Poland's Chief Pharmaceutical Inspectorate (GIF) has withdrawn 25 batches of the painkilling gel Olfen MAX across the country. The decision takes effect immediately, which means these batches may no longer be sold by pharmacies or wholesalers. The reason is that the gel exceeded the limit for NDEA, an impurity with mutagenic and carcinogenic potential. GIF supervises the quality of medicines available in Poland and can order a product off the market when its quality is in doubt.

Which packs are affected

The decision concerns Olfen MAX gel containing 20 mg/g diclofenac sodium, made by Teva B.V. Two batches in 50 g tubes, 18 in 100 g tubes and 5 in 150 g tubes were recalled. Their expiry dates run from November 2026 to March 2027, so packs like these may still be sitting in home medicine cabinets. Diclofenac is a common non-steroidal anti-inflammatory drug. As a gel it is applied to the skin, for example for muscle and joint pain, bruises or sprains.

What NDEA is

NDEA, or N-nitrosodiethylamine, belongs to the nitrosamines, a group of chemical compounds that can form during the manufacture or storage of medicines. Because they can damage genetic material, manufacturers must keep them within strict limits. According to GIF, the quality defect means the safety of the affected batches cannot be confirmed. The available information does not say by how much the limit was exceeded. Small amounts of nitrosamines are also found in smoked and cured foods and in tobacco smoke. Nor is the problem new: in recent years other medicines have also been withdrawn because of them.

Is there cause for concern?

A recall is above all a precaution: if a product's safety cannot be confirmed, it is taken off the market. Limits for impurities of this kind are usually set with long-term exposure in mind rather than a single use. Anyone who has used gel from a recalled batch and has concerns should speak to a pharmacist or doctor.

How to check your gel

The batch number is printed on the tube and the box, usually next to the expiry date. For the 50 g tubes the recalled batches are C51789A and C51790A, and the 150 g batches include B70993C. Most of the recalled batches, 18 of the 25, are 100 g tubes. The full list is in the GIF notice. It is worth comparing the numbers character by character, as consecutive batches may differ only in the last digits, like C51789A and C51790A. The decision does not cover other batches of Olfen MAX or other diclofenac medicines.

What to do with a recalled pack

The notice gives no detailed advice on returns, so it is best to ask at a pharmacy. Unwanted medicines should not be thrown out with household rubbish or poured down the drain; they can be dropped into the special collection bins found in many pharmacies. If you still need the gel for treatment, a pharmacist can advise on an alternative.