Lorafen

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

An out-of-specification result was found in long-term stability testing (parameter: active substance release below the lower acceptance limit), which constitutes a real and direct threat to patients' health or life. Potential effects: reduced treatment efficacy, disease exacerbation, complications endangering health or life.

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Risk Level

High

Manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.

Batch Number

41124, 51124

Notice Date

17.12.2025

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 Lorafen, 1 mg, coated tablets from batches 41124 and 51124. If you have packs from these batches, consult your doctor or pharmacist to determine further steps and possible replacement of t...

Actions Taken

The Chief Pharmaceutical Inspector suspended the marketing of Lorafen, 1 mg, coated tablets in Poland for batches 41124 and 51124. The decision was given immediate enforceability. The marketing auth...

Need Help?

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

Lorafen

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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