Quality & complianceOfficial

MHRA recalls one batch of Accord lercanidipine 10mg tablets after 20mg strip found in carton

🇬🇧 MHRA alerts · Thu 29 Oct 2026

Class 2 recall EL(26)A/45 targets pharmacy and wholesaler stock after a single complaint of mixed strengths inside a sealed pack.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall, EL(26)A/45, for one batch of Accord-UK Ltd Lercanidipine Hydrochloride 10mg Film-Coated Tablets. The cause is a packaging mix-up involving the incorrect strength. The notice was published on 29 October 2026.

The affected lot is M2510877, in packs of 28 with an expiry date of November 2028. It was first distributed on 24 June 2026. The product licence is PL 00142/1154 and the DMRC reference is 41285957.

Accord has received one complaint so far. A sealed carton of the 10mg tablets from the affected batch contained one blister strip of the correct product and one strip of lercanidipine 20mg tablets from batch M2510831. The company has shown that the likelihood of a mix-up, and the resulting risk to patients, is low, so the recall is limited to pharmacy and wholesaler level rather than reaching patients.

The notice says a patient who inadvertently took 20mg daily for around two weeks instead of 10mg could experience an exaggerated pharmacological effect, notably lower blood pressure, with symptoms such as dizziness, headache, flushing, palpitations or symptomatic hypotension. It adds that 20mg is still within the authorised therapeutic dose range for routine use, and that the two tablet strengths are distinctly coloured.

Healthcare professionals are told to stop supplying the batch immediately, quarantine remaining stock and return it through their supplier's approved process. If a patient presents a pack containing the wrong medicine, pharmacy teams should use professional judgement to supply the correct product. Patients with a pack from the batch are advised to check the blister strips: if all are labelled 10mg, they can carry on; if any strip is labelled 20mg, they should not take it and should contact their pharmacy. Anyone who thinks they have taken the 20mg tablets and has symptoms should seek immediate medical advice, and suspected adverse reactions can be reported through the Yellow Card scheme.

What it means for your team

  • Wholesalers and pharmacies should check for batch M2510877, stop supply and quarantine stock for return via their supplier.
  • Quality teams should note the failure mode: a mixed-strength blister inside a sealed carton points to a packaging-line control issue, although only one complaint has been received so far.
  • Pharmacy teams should be ready to check returned or presented packs and replace any carton that contains a 20mg strip.
  • Pharmacovigilance teams should expect possible Yellow Card reports of hypotension-type symptoms linked to this batch.

Official source: MHRA alerts ↗

Article written by VigiEye from the official source (MHRA alerts). AI-assisted; check the source before acting.

More Quality & compliance All →