Medicines recallMHRA
Lercanidipine HCl 20mg Tablets, Recordati Industria recalled over a strength or dose problem
Recordati Pharmaceuticals Limited has informed the MHRA of an error in the strength of the product printed on some of the faces (sides) of the product carton. The error is limited to one batch of Lercanidipine HCl 20mg Tablets. The packs are incorrectly labelled as 10mg on some sides of the product carton when they are 20mg tablets.
Check your product
Only products that match these details are covered. Have your pack in front of you.
3 identifiers listed for this notice.
Lercanidipine HCl 20mg Tablets, Recordati Industria 28
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- MD4L07
- ExpiryOn the carton, blister or label.
- 01/2028
- First distributedOn the product, its label or its packaging.
- 10/04/2025
What to do now
The problem with Lercanidipine HCl 20mg Tablets, Recordati Industria is strength: the dose in the affected batches may be higher or lower than the label says.
- 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.
- If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
- 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
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/17). Quoted as issued.
Summary
Recordati Pharmaceuticals Limited has informed the MHRA of an error in the strength of the product printed on some of the faces (sides) of the product carton. The error is limited to one batch of Lercanidipine HCl 20mg Tablets. The packs are incorrectly labelled as 10mg on some sides of the product carton when they are 20mg tablets.
The risk
DMRC reference number DMRC Ref: 35334038 Marketing Authorisation Holder
Advice for healthcare professionals
Stop supplying the above batch immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process. This medicine is being recalled as a precautionary measure.
Pharmacists who have been supplied this batch and suspect they have dispensed the tablets to patients should contact the patient immediately to make them aware of this error. Please see ‘advice for patients’ section below.
Patients who have been prescribed 10 mg tablets and have received tablets with this batch number (printed on the foil of the blister strips) should contact your pharmacist or GP immediately. In the event that the GP or pharmacist cannot be reached, please call NHS 111 for advice on continuing your medication. In the event you cannot speak to a healthcare professional before you are due to take your next dose:
verify the strength of the tablets is 20 mg from the information on the foil of the blister strips
remove one tablet from the blister as normal
locate the break line on the tablet
snap the tablet in half across the break line and take half of the tablet. This is permitted for the 20mg tablets and is in line with information included in the patient information leaflet (where it states ‘The tablet can be divided into equal doses’).
Patients who have been prescribed 20 mg tablets should verify the strength of the tablets by checking the information on the foil of the blister strips prior to taking the tablet. Continue to take the tablets as prescribed by your doctor.
Do not stop taking your medicine without consulting your healthcare provider. Patients who are concerned about the strength of the medication they have received should check it with their dispensing pharmacy.
Patients concerned they may have accidentally taken a higher dose of the medication than they were prescribed should seek medical attention.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Advice for patients
Patients who have been prescribed 10 mg tablets and have received tablets with this batch number (printed on the foil of the blister strips) should contact your pharmacist or GP immediately. In the event that the GP or pharmacist cannot be reached, please call NHS 111 for advice on continuing your medication. In the event you cannot speak to a healthcare professional before you are due to take your next dose:
verify the strength of the tablets is 20 mg from the information on the foil of the blister strips
remove one tablet from the blister as normal
locate the break line on the tablet
snap the tablet in half across the break line and take half of the tablet. This is permitted for the 20mg tablets and is in line with information included in the patient information leaflet (where it states ‘The tablet can be divided into equal doses’).
Patients who have been prescribed 20 mg tablets should verify the strength of the tablets by checking the information on the foil of the blister strips prior to taking the tablet. Continue to take the tablets as prescribed by your doctor.
Do not stop taking your medicine without consulting your healthcare provider. Patients who are concerned about the strength of the medication they have received should check it with their dispensing pharmacy.
Patients concerned they may have accidentally taken a higher dose of the medication than they were prescribed should seek medical attention.
Patients who experience adverse reactions or have any questions about the 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 Lercanidipine HCl 20mg Tablets, Recordati Industria been recalled?
The problem with Lercanidipine HCl 20mg Tablets, Recordati Industria is strength: the dose in the affected batches may be higher or lower than the label says. 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?
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.