Recalled medicines and products GIF — current list 2026
GIF — Chief Pharmaceutical Inspectorate
GIF (the Chief Pharmaceutical Inspectorate) issues decisions to suspend and withdraw medicines and pharmaceutical products from the market when quality, safety or batch problems arise. The list below brings together medicines recalled by the Chief Pharmaceutical Inspectorate in one place and is updated continuously.
353 alerts in the database • last update:
Latest recalled products from GIF
POLYVACCINUM MITE
In one bottle of the medicinal product batch a solid body floating on the surface of the suspension was found, which poses a potential risk to patients' health. Potential effects: complications after administration, irritation, inflammatory reaction, lack of therapeutic efficacy.
BDS N
Out-of-specification results were found for the content of related substances of budesonide, due to exceeded impurity levels. Potential effects: lack of treatment efficacy or adverse reactions caused by impurities.
ROZAPROST MONO
No information in the text about the type of hazard, contamination, quality defect or safety issue concerning a specific medicinal product or batch. Potential effects: impossible to assess risk, need to exercise caution until full data are obtained.
ROZAPROST MONO
No information in the text about any specific hazard to the quality, safety, or efficacy of any medicinal product. Potential effects: no effects can be determined based on the available information.
BENODIL
Risk of not meeting finished product specification with respect to the parameter of related substances content, which may indicate a quality defect of the medicinal product. Potential effects: lack of efficacy or unpredictable adverse reactions.
BENODIL
A risk was identified that the finished product may not meet specification requirements regarding the level of related substances, indicating a possible quality defect. Potential effects: possible lack of efficacy or unpredictable adverse reactions.
BUDIXON NEB
Exceeding the specification limit for the parameter of budesonide-related substances content was found, meaning the product does not meet established quality requirements. Potential effects: possible lack of treatment efficacy or adverse reactions.
BDS N
It was confirmed that the specification limit for the parameter 'content of related substances' was exceeded, due to an increased level of impurities. Potential effects: possible adverse reactions, toxicity, lack of therapeutic efficacy.
BDS N
The specification limit for the parameter "content of related substances" was exceeded due to increased impurity content, constituting a quality defect of the medicinal product and a potential risk to patients' health. Potential effects: poisoning, adverse reactions, lack of therapeutic efficacy.
ASANIX
A quality defect was found: in the ongoing stability testing program an out-of-specification result was obtained for the parameter of active substance release from the tablet, meaning the drug may not release the correct amount of active ingredient. Potential effects: lack of treatment efficacy or unpredictable drug action.
BENODIL
It was found that the specification limit for the related substances content parameter was exceeded, meaning the product does not meet established quality requirements. Potential effects: possible lack of efficacy, unpredictable adverse reactions.
3% ROZTWÓR KWASU BOROWEGO
A quality defect was found: boric acid content 0.3% instead of the required 2.8–3.2% and a non‑compliant form of the raw material, which may lead to compounding magistral medicines with incorrect strength. Potential effects: lack of treatment efficacy, possible disease complications.
3% ROZTWÓR KWASU BOROWEGO
A quality defect was found: boric acid content is 0.3% instead of 2.8%-3.2% and the form is non-compliant, which may lead to compounded medicines with incorrect strength and efficacy. Potential effects: lack of therapeutic efficacy, possible disease complications.
3% ROZTWÓR KWASU BOROWEGO
A quality defect was found: too low boric acid content (should be 2.8%–3.2%, actual 0.3%) and non‑compliant form, which may lead to preparation of compounded medicines with incorrect strength and effectiveness. Potential effects: lack of drug efficacy, risk of therapy complications.
CALCIUM POLFARMEX (O SMAKU TRUSKAWKOWYM)
A quality defect of the medicinal product was found in the form of an improper smell of the syrup, which may indicate irregularities in the composition or stability of the product. Potential effects: lack of efficacy, possible irritation or other adverse reactions.
ARTHRYL
The defect consists in the use of incorrect serialization data, resulting in incorrect identification of the medicinal product and failure to meet requirements for verification of authenticity and identification of the pack. Potential effects: possible use of an inappropriate or falsified drug, lack of treatment efficacy, treatment complications.
VALZEK
This risk may be caused by the presence of N-nitrosodimethylamine (NDMA) contamination in the active substance contained in the medicinal product, which may affect human health and life. Potential effects: possible carcinogenic effects and other serious health disorders with long-term exposure.
VALZEK
Presence of N-nitrosodimethylamine (NDMA) contamination above the acceptable limit was found in the active substance Valsartan, which may pose a threat to patients' health and life. Potential effects: poisoning, carcinogenic effects, health complications with long-term use.
REMUREL
It was found that the tested sample of the medicinal product does not meet the manufacturer's specification regarding the parameter: contamination with particles invisible to the naked eye. Potential effects: complications after injection, inflammatory reactions, lack of treatment safety.
OZURDEX
A silicone particle of about 300 µm in diameter was detected in some batches of the medicinal product Ozurdex, which constitutes a potential quality defect and may pose a risk to patients' health. Potential effects: complications after administration, tissue irritation, visual disturbances, serious ophthalmic complications.
LECALPIN
It was found that in the outer cartons intended for the medicinal product Lecalpin 20 mg there were primary packages (blisters) of the medicinal product Lecalpin 10 mg, batch No. 268018. Potential effects: lack of treatment efficacy or improper dosing.
MILVANE
Lack of information on contraindications for the use of the medicinal product Milvane in combination with certain medicines used in antiviral therapy. Potential effects: lack of efficacy, adverse reactions, treatment complications.
KALIUM EFFERVRSCENS BEZCUKROWY
Repeated complaints were reported regarding incorrectly printed expiry dates and it was found that the products lacked a unique identifier and tamper-evident safety feature on the packaging, as well as batch certification and release by the Qualified Person. Potential effects: lack of treatment efficacy, use after expiry, falsification risk, treatment complications.
SPASMOLINA
Incorrect expiry date was printed on outer packaging and required safety features (unique identifier and anti-tampering device) were missing, combined with lack of batch certification and release by the Qualified Person. Potential effects: lack of treatment efficacy, use of the product after expiry date, risk of falsification or tampering, treatment complications.
ANDEPIN
Lack of a unique identifier and tamper‑evident feature, together with incorrect expiry date labelling, may prevent proper medicine identification and facilitate circulation of unauthorised or expired packs. Potential effects: lack of treatment efficacy or complications related to use of expired or falsified medicine.
SPASMOLINA
Failure to include a unique identifier and tamper-evident feature on the packaging and placing the batch on the market without recertification and release by the Qualified Person may result in distribution of a product with unverified quality and authenticity. Potential effects: lack of efficacy or complications due to use of a product with unconfirmed quality.
ENEMA
Identified risk of a decrease in the content of the preservative – methyl parahydroxybenzoate, meaning the product may not meet established quality requirements and may not ensure adequate microbiological stability. Potential effects: lack of efficacy, infections, complications in patients.
NuTRiflex Lipid special
It was found that the glucose solution may not meet specification requirements at the end of shelf-life, indicating a quality defect of the medicinal product and a potential threat to patients’ health or life. Potential effects: lack of treatment efficacy, metabolic disturbances, complications after infusion.
XALOPTIC FREE
Exceeding specification limits for related substances content in several batches of Xaloptic Free and suspected occurrence of the same quality defect in further batches, indicating non‑compliance with quality requirements. Potential effects: lack of treatment efficacy, adverse reactions, therapy complications.
XALOPTIC FREE
It was found that the specification limit for related substances was exceeded in batches of the medicinal product Xaloptic Free, with a likelihood of this non‑compliance occurring in further batches. Potential effects: possible lack of efficacy or unforeseen adverse reactions.
ROTARIX
Irregularities in the manufacturing process were detected, leading to possible insufficient filling of the last 50 oral applicators of the Rotarix batch, meaning failure to meet quality requirements for the volume parameter. Potential effects: lack of vaccination efficacy.
BENZACNE
A quality defect of the product was found regarding the gel appearance and active substance content, resulting from a defect of the immediate packaging, which may lead to improper quality and performance of the product. Potential effects: lack of treatment efficacy or unpredictable drug action.
BENODIL
A quality defect was identified consisting of out-of-specification results for the parameter of budesonide-related substances content, which may indicate an improper impurity profile and lack of compliance with quality requirements. Potential effects: possible reduced treatment efficacy or increased risk of adverse reactions.
BENODIL
Out-of-specification results were found in archival samples tested by the manufacturer, regarding the parameter of budesonide-related substances content, which means failure to meet established quality requirements. Potential effects: possible lack of treatment efficacy or unforeseen adverse reactions.
PRESARTAN H
Detected nitrosamine-group impurities (NDMA and NDEA) in the active substance losartan potassium, which may affect human health and life, even though the levels do not exceed acceptable limits. Potential effects: possible carcinogenic effects and health complications with long-term use.
PRESARTAN H
The risk may be caused by the presence of nitrosamine-group contaminants in the active substance contained in these medicinal products, which may affect human health and life. Potential effects: possible carcinogenic effects, chronic health risk, potential complications with long-term use.
PRESARTAN
This risk may be caused by the presence of nitrosamine-group impurities in the active substance contained in the above-mentioned medicinal products, which may affect human health and life. Potential effects: possible carcinogenic effects and health complications during long-term use.
PRESARTAN
Impurities of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) were detected in the active substance Losartanum kalicum from the manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd. Potential effects: possible carcinogenic effects and health risks with long-term use.
KORZEŃ ARCYDZIĘGLA
Failure to meet quality requirements of the medicinal product was found due to the presence of disqualifying features, which makes a potential risk to patients’ health or life plausible. Potential effects: lack of efficacy, possible adverse effects or health complications.
GLICEROL
Out-of-specification results were found for aldehydes, sugars, impurity A and related substances during stability testing of batch 01916, which makes a potential threat to the quality and safety of the medicinal product plausible. Potential effects: lack of efficacy or unforeseen adverse reactions.
BUDIXON NEB
Test results out of specification in archival samples concerning the content of budesonide related substances. Potential effects: reduced efficacy, increased risk of adverse reactions.
BUDIXON NEB
Out-of-specification results for the content of budesonide-related substances. Potential effects: reduced efficacy or increased risk of adverse reactions.
BENODIL
Test results out of specification: elevated related substances content of budesonide. Potential effects: reduced efficacy, increased risk of adverse reactions.
BENODIL
Out-of-specification results for related substances of budesonide. Potential effects: reduced efficacy or altered safety of use.
BDS N
Out-of-specification results for the content of related substances of budesonide. Potential effects: reduced efficacy or safety of the medicinal product.
APO-LOZART
Detected contamination with N-nitroso-N-methylamino butyric acid (NMBA) in some batches of the losartan potassium active substance. Potential effects: carcinogenicity, increased long-term health risk.
APO-LOZART
Detected contamination of the active substance with N-nitroso-N-methylamino-butyric acid (NMBA), an N-nitrosamine that may affect human health and life. Potential effects: increased cancer risk, systemic toxic effects.
LOREBLOK HCT
Detection of contamination: N-nitroso-N-methylamino-butyric acid (NMBA) in the active substance losartan. Potential effects: long-term carcinogenic risk.
LOREBLOK
Contamination with N-nitroso-N-methylamino butyric acid (NMBA) was detected in some batches of the losartan active substance (from Hetero Labs Limited). Potential effects: increased risk of carcinogenic effects with long-term exposure.
IRPRESTAN
Detection of N-nitrosodiethylamine (NDEA) above the acceptable limit in the active substance sourced from Zhejiang Huahai. Potential effects: carcinogenic action and long-term health risk.
PECFENT
Suspected defect in the primary packaging of the PecFent batch, potentially causing loss of seal/integrity. Potential effects: incorrect dose (evaporation of solution), risk to health and life.
XALOPTIC FREE
Does not meet specification: elevated impurity content — 15(5)-latanoprost, single unknown impurities and increased sum of unknown and total impurities. Potential effects: risk of adverse reactions or reduced efficacy.
FLUCINAR N
Out-of-specification result in a reference sample — impurities originating from fluocinolone acetonide. Potential effects: reduced efficacy, skin adverse effects (irritation, allergic reactions).
Recalls by source
Frequently asked questions
What are GIF alerts?
GIF (Chief Pharmaceutical Inspectorate) alerts are decisions to suspend or withdraw medicines and pharmaceutical products from the market due to quality or safety issues.
What to do if you bought a recalled product?
Stop using or consuming the product immediately. Most recalled products can be returned to the store for a full refund, even without a receipt. On each alert page you will find a direct link to the official report with detailed information from the authorities.
What to do if you have this product?
A recall means the product may be unsafe. Here is what to do if you have it at home.
-
1
Do not eat or use the product
Stop using or consuming it immediately and keep it out of reach of children.
-
2
Check the batch number and expiry date
Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
-
3
Return it to the shop
You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
-
4
Get help and report it
If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.
General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.