GIF withdraws 25 batches of Olfen MAX painkiller gel over nitrosamine impurity
Poland's chief pharmaceutical inspectorate ordered the immediate withdrawal of 25 batches of the diclofenac gel nationwide after NDEA levels exceeded the permitted limit. The decision was taken on Monday, 12 October 2026.
Nationwide withdrawal
The Główny Inspektorat Farmaceutyczny (GIF) has ordered the withdrawal of selected batches of Olfen MAX, a diclofenac gel at 20 mg/g, from the market across Poland. Onet reports that the decision was taken on Monday, 12 October 2026, and covers 25 batches in 50 g, 100 g and 150 g tubes. Most outlets name Teva B.V. as the manufacturer, while Onet gives the responsible entity as eva B.V., based in the Netherlands. The decision carries an order of immediate enforceability (rygor natychmiastowej wykonalności), so the withdrawal and the ban on further placing the batches on the market take effect at once.
Why the batches were pulled
The reason is a quality defect: the permitted limit for N-nitrosodiethylamine (NDEA) was exceeded. NDEA belongs to the nitrosamine impurities, which are subject to strict limits because of their potentially mutagenic and carcinogenic effect. Diclofenac sodium, the active ingredient, is a non-steroidal anti-inflammatory drug (NLPZ) used, among other things, to relieve post-traumatic pain and inflammation. GIF's statement says that exceeding the limit means the product does not meet the conditions for market authorization.
NDEA belongs to nitrosamine impurities, for which limits are set due to their mutagenic and carcinogenic potential. Exceeding this limit means the product does not meet the conditions for placing on the market and does not allow confirming the safety of the batches covered by the decision.
According to Onet, stability tests found the limit exceeded during longer storage. The impurity content could exceed the set norms after 18 months, while the withdrawn batches had been sold with a 24-month shelf life.
Affected batches
The decision covers two batches in 50 g tubes, eighteen in 100 g tubes and five in 150 g tubes. The 50 g batches are C51789A and C51790A, both with expiry 01.2027. Of the 100 g batches, nine expire in 11.2026, three in 02.2027 and six in 03.2027. In the 150 g size, B70993C and B70994A expire in 11.2026, while C53137A, C53136B and C53039B expire in 02.2027. The withdrawal does not cover every pack of the product automatically, so the batch number printed on each box decides whether it is affected.
- 50 g tubes
- 2 batches
- 100 g tubes
- 18 batches
- 150 g tubes
- 5 batches
What patients should do
Patients who keep Olfen MAX at home should read the batch number on the packaging and compare it with the GIF list. If the number matches, the gel should not be used, and a pharmacist can advise on next steps. The inspectorate's statement says the batches covered by the decision cannot be confirmed as safe, so a valid expiry date does not change that instruction. The decision applies throughout the country, and the list of batch numbers in the GIF decision is the reference point for every affected pack.
