Xaloptic Combi

GIF decision: Withdrawal from market, Marketing prohibition

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Increased solution osmolality and water loss leading to reduced volume may destabilize the tear film and cause ocular discomfort, irritation, burning, subjective visual disturbances, and worsening of dry eye symptoms, especially with long-term use of the product. Potential effects: eye irritation and discomfort, worsening dryness, possible transient visual disturbances.

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Risk Level

Medium

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Batch Number

04634, 04734, 04834, 048342

Notice Date

24.11.2025

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.

Important Information

What You Should Know

Recommendations

Do not use Xaloptic Combi eye drops from batches 04634, 04734, 04834 and 048342; check the batch number on the packaging and, if you have these batches, return the product to the pharmacy or consult a...

Actions Taken

Withdrawal from the market of Xaloptic Combi batches 04734 and 048342 throughout the country, prohibition of placing batches 04634, 04734, 04834 and 048342 on the market, and granting the decision imm...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Xaloptic Combi

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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