MHRA Guidance & Safety

MHRA Class 2 Recall: Crescent Pharma Ramipril 5mg Capsules

The MHRA has issued a Class 2 medicines recall for one batch of Crescent Pharma Limited's Ramipril 5mg Capsules due to a manufacturing error where incorrect blister strips were found in the packaging. Healthcare professionals are instructed to stop supplying the affected batch immediately and contact patients who received the product.

UK Agencies Support In-Orbit Pharmaceutical Manufacturing

The UK Space Agency, MHRA, RIO, and CAA have issued a joint statement outlining their support for companies involved in in-orbit pharmaceutical manufacturing. This initiative aims to foster a supportive regulatory environment through guidance and collaborative studies, reinforcing the UK's commitment to space-enabled manufacturing.

MHRA Field Safety Notices - February 23-27, 2026

The MHRA has published a list of five Field Safety Notices (FSNs) issued between February 23-27, 2026, for medical devices. These notices are for informational purposes, and recipients are advised to contact the manufacturer with any questions.

MHRA Statement on Pathways Clinical Trial Safety

The MHRA has issued a statement regarding the Pathways clinical trial, emphasizing participant safety. As a precaution, Professor Jacob George has been recused from further involvement due to social media posts made prior to his appointment.

MHRA Raids Illegal Weight Loss Medicine Facility

The MHRA has raided two facilities suspected of manufacturing and selling illegal weight loss medicines, seizing nearly 2,000 doses and manufacturing equipment. This action is part of an ongoing investigation into a criminal network and aims to protect the public from dangerous, unregulated products.

MHRA Approves Imlunestrant Tosylate for Breast Cancer

The MHRA has approved imlunestrant tosylate (Inluriyo), a new treatment for adult patients with a specific type of advanced or metastatic breast cancer. This approval provides a new therapeutic option for patients who have not responded to prior hormonal treatment.

MHRA Alert: Fake Mounjaro (tirzepatide) KwikPens

The MHRA has issued a notice regarding fake Mounjaro (tirzepatide) 15mg KwikPens dispensed by The Private Pharmacy Clinic in Birmingham. Patients with affected pens are advised to stop use immediately and report to the MHRA. The manufacturer reported five faulty pens.

MHRA Class 2 Medicines Recall: KidNaps Melatonin Oral Solution

The MHRA has issued a Class 2 medicines recall for all batches of KidNaps Melatonin 1mg in 1ml Oral Solution due to out-of-specification stability results. Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are conducting the recall at the wholesaler and pharmacy level.

MHRA Licenses Brensocatib for Non-Cystic Fibrosis Bronchiectasis

The MHRA has granted a marketing authorisation for brensocatib (Brinsupri), the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 years and older. This marks a significant advancement in treatment options for NCFB patients in the UK.

MHRA Statement on PATHWAYS Puberty Blocker Trial Safety

The MHRA has issued a statement regarding the PATHWAYS puberty blocker trial, expressing concerns about participant wellbeing and initiating scientific dialogue with the trial sponsor, King's College London. The agency is applying high scrutiny to ensure the safety of potential child and young person participants.