Batch BeaconUK recalls and safety alerts

Medicines defect noticeMHRA

Loperamide hydrochloride 2 mg Orodispersible Tablets defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets.

Check your product

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

7 identifiers listed for this notice.

  • Product 1 12 orodispersible tablets

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 25882X3
    Product licenceThe PL number on the carton.
    • PL 16363/0784
    ExpiryOn the carton, blister or label.
    • 30/11/2029
    First distributedOn the product, its label or its packaging.
    • 17/12/2025

  • Product 2 6 orodispersible tablets

    Batch code
    • 25882X2
    Expiry
    • 30/11/2029
    First distributed
    • 17/12/2025

What to do now

A printing or labelling mistake affects some packs of Loperamide hydrochloride 2 mg Orodispersible Tablets.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. Report suspected side effects to the MHRA 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

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.

An affected pack bought over the counter can be returned to where you bought it.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/23). Quoted as issued.

Summary

Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets.

The risk

DMRC reference number DMRC - 39394163 Marketing Authorisation Holder

Advice for healthcare professionals

Healthcare professionals are asked to note the PIL discrepancies described above for batches 25882X3 and 25882X2 of Loperamide hydrochloride 2 mg Orodispersible Tablets (PL 16363/0784) and share this information with patients, where appropriate.

The correct administration instructions are printed on the carton. Milpharm Limited have confirmed that all future batches will be packed with the corrected PIL.

Healthcare professionals should be aware that “burning or prickling sensation of the tongue” is a recognised rare local adverse effect (frequency up to 1 in 1,000) of the orodispersible formulation, even though it is not currently listed in the affected PIL. Should a patient report this symptom following administration, it should be considered a potential medication-related effect and managed accordingly.

If you have been dispensed Loperamide hydrochloride 2 mg Orodispersible Tablets from batch 25882X3 (pack of 12) or batch 25882X2 (pack of 6), please note the following:

How to take the tablets: Place the tablet on your tongue and let it dissolve in your mouth. You do not need water to swallow it. Do not chew the tablet. The leaflet inside the pack may incorrectly tell you to swallow the tablet whole with water — please follow the instructions on the carton (outer pack) and the advice in this notice instead.

Possible side effect to be aware of: A rare side effect (which may affect up to 1 in 1,000 people) of this orodispersible tablet is a burning or prickling sensation of the tongue. This side effect is not currently listed in the leaflet inside the pack. If you experience this, please speak to your doctor or pharmacist.

You do not need to return the medicine. You can continue to use it as prescribed, following the corrected instructions above.

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

If you have been dispensed Loperamide hydrochloride 2 mg Orodispersible Tablets from batch 25882X3 (pack of 12) or batch 25882X2 (pack of 6), please note the following:

How to take the tablets: Place the tablet on your tongue and let it dissolve in your mouth. You do not need water to swallow it. Do not chew the tablet. The leaflet inside the pack may incorrectly tell you to swallow the tablet whole with water — please follow the instructions on the carton (outer pack) and the advice in this notice instead.

Possible side effect to be aware of: A rare side effect (which may affect up to 1 in 1,000 people) of this orodispersible tablet is a burning or prickling sensation of the tongue. This side effect is not currently listed in the leaflet inside the pack. If you experience this, please speak to your doctor or pharmacist.

You do not need to return the medicine. You can continue to use it as prescribed, following the corrected instructions above.

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 Loperamide hydrochloride 2 mg Orodispersible Tablets been recalled?

A printing or labelling mistake affects some packs of Loperamide hydrochloride 2 mg Orodispersible Tablets. 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, product licence, 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?

Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.

Do I need a new prescription?

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.

Related notices