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Medicine recalls and shortages › Recalls and defects › 17 Apr 2025
Medicines recall

Lercanidipine HCl 20mg Tablets

Issued on 17 Apr 2025 · source: MHRA — Medicines and Healthcare products Regulatory Agency
Affected batches: MD4L07 (01/2028)
Check the batch number on the pack. The medicine remains licensed; other batches are not affected.
Class 2 recall · PL: 04595/0011 · licence holder: Recordati Industria Chimica e Farmaceutica S.p.A. Via Matteo Civitali, 1 - 20148 Milan, ITALY. · active ingredient: lercanidipine hydrochloride · licence PL: 04595/0011

What this means

The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.

Class 2 recall

ProductLicenceActive ingredientGTIN
Lercanidipine HCl 20mg TabletsPL: 04595/0011lercanidipine hydrochloride8057742821983

Batches (expiry): MD4L07 (01/2028)

Background: 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 the batch of Lercanidipine HCl 20mg Tablets listed in the table above. The packs of 20mg tablets are incorrectly labelled as 10mg on some sides of the product carton. The correct strength (20mg) is printed on the top of the carton and on the blister strips. Recordati Pharmaceuticals Limited is initiating a recall of the specified batch as a precautionary measure. 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 conta

Tracked from information published by the MHRA and the NHSBSA. This information is for guidance only and does not replace advice from your doctor or pharmacist.