Batch BeaconUK recalls and safety alerts

Medicines defect noticeMHRA

Baclofen 10mg Tablets defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.

Check your product

Only products that match these details are covered. Have your pack in front of you.

5 identifiers listed for this notice.

  • Baclofen 10mg Tablets 84

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • EBJ25001F01
    • EBJ25002F01
    • EBJ25003F01
    ExpiryOn the carton, blister or label.
    • 31/01/2028
    First distributedOn the product, its label or its packaging.
    • 14/08/2025

What to do now

The issue with Baclofen 10mg Tablets is information: something on the packaging or leaflet is wrong or missing.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.

Symptoms and when to get help

Look out for

  • a side effect you have not had before
  • your condition not being controlled as well as usual

Get help urgently

  • signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
  • if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/51). Quoted as issued.

Summary

Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.

The risk

DMRC reference number DMRC - 37308281 Marketing Authorisation Holder

Advice for healthcare professionals

The quality of the tablets is not impacted by this issue; therefore the affected batches are not being recalled. Healthcare professionals are advised to review the information contained within this notification and take this into account when dispensing these products, especially for new patients.

If the medicine listed in this notification are dispensed, ensure that patients are aware of the missing information. Please see the updated PIL for the correct information.

Upon request, Special Concept Development UK Limited will provide hard copies of the PIL to pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact medinfo@rxfarma.co.uk with your details, i.e. address, product with batch details, required number of leaflets.

Special Concept Development UK Limited has confirmed that all future batches will contain the correct PIL.

This issue is about missing information on the Patient Information Leaflets (PILs) in the batches of Baclofen 10mg tablets included in the table. The quality of the tablets is not affected.

If you have concerns about the medicine you are using, please contact your healthcare professional in the first instance.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Advice for patients

This issue is about missing information on the Patient Information Leaflets (PILs) in the batches of Baclofen 10mg tablets included in the table. The quality of the tablets is not affected.

If you have concerns about the medicine you are using, please contact your healthcare professional in the first instance.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Open the MHRA notice

Questions

Why has Baclofen 10mg Tablets been recalled?

The issue with Baclofen 10mg Tablets is information: something on the packaging or leaflet is wrong or missing. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.

How do I know if my medicine is affected?

Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

Do I need a new prescription?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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