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Medicines defect noticeMHRA

Dulcolax Adult 5 mg Gastro-resistant Tablets, Opella Healthcare defect notice over a strength or dose problem

Wrong strength or doseLow riskClass 4

Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets (packsize 20 count). The dose instruction incorrectly states for use in 12 years and older. These general sale packs are intended for use only in adult patients (18 years and over).

Check your product

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

15 identifiers listed for this notice.

  • Dulcolax Adult 5 mg Gastro-resistant Tablets, Opella Healthcare 20

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 240908
    • 240909
    • 241873
    • 241875
    • 250222
    • 250307
    • 250308
    ExpiryOn the carton, blister or label.
    • 31/05/2027
    • 30/11/2027
    • 31/12/2027
    • 31/01/2028
    First distributedOn the product, its label or its packaging.
    • 25/04/2025
    • 24/04/2025
    • 07/05/2025
    • Not yet distributed

What to do now

Some batches of Dulcolax Adult 5 mg Gastro-resistant Tablets, Opella Healthcare may not contain the right amount of active ingredient.

  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. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.

Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/26). Quoted as issued.

Summary

Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets (packsize 20 count). The dose instruction incorrectly states for use in 12 years and older. These general sale packs are intended for use only in adult patients (18 years and over).

The risk

DMRC reference number DMRC-35546901 Marketing Authorisation Holder

Advice for healthcare professionals

Healthcare professionals and retailers are advised to review the information contained within this notification and where possible, customers should be informed that Dulcolax Adult 5mg GR Tablets is approved for adult use only and to take the product as indicated in the Patient Information Leaflet (PIL) or based on advice from their healthcare professional.

Please see a link to the Patient Information Leaflet (PIL) for further information.

Adult patients should continue to take medicines from the impacted batches. The quality of the product is not affected which is why the products are not being recalled and will remain to be available for sale.

There is an error on the back of the carton, this product is only intended for use by adults (18 years and over) and should not be used in children (under the age of 18). Ensure that you follow the information provided in the patient information leaflet.

Based on the safety assessment, it was concluded that there is no harm expected to children who may have taken this medication. Dulcolax Twelve Plus tablets (‘P’ pack) have the same active ingredient (Bisacodyl) and same strength (5mg) as Dulcolax Adult GR tablets (‘GSL’ pack).

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

Adult patients should continue to take medicines from the impacted batches. The quality of the product is not affected which is why the products are not being recalled and will remain to be available for sale.

There is an error on the back of the carton, this product is only intended for use by adults (18 years and over) and should not be used in children (under the age of 18). Ensure that you follow the information provided in the patient information leaflet.

Based on the safety assessment, it was concluded that there is no harm expected to children who may have taken this medication. Dulcolax Twelve Plus tablets (‘P’ pack) have the same active ingredient (Bisacodyl) and same strength (5mg) as Dulcolax Adult GR tablets (‘GSL’ pack).

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 Dulcolax Adult 5 mg Gastro-resistant Tablets, Opella Healthcare been recalled?

Some batches of Dulcolax Adult 5 mg Gastro-resistant Tablets, Opella Healthcare may not contain the right amount of active ingredient. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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?

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

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