MHRA Guidance & Safety

MHRA Approves Deuruxolitinib (Leqselvi) for Severe Alopecia Areata

The UK's MHRA has approved deuruxolitinib (Leqselvi) for the treatment of severe alopecia areata in adults. This marks a new treatment option for patients and will be kept under close review for safety and effectiveness.

MHRA Advertising Investigations and Decisions

The MHRA has published decisions following investigations into advertising complaints for licensed medicines, specifically concerning weight loss treatments. Ten decisions were made in February 2026 regarding websites and services that highlighted medicinal treatments for weight loss.

Ramipril Recall Due to Packaging Error

The MHRA has issued a precautionary recall for one batch of Ramipril 5 mg Capsules (Batch Number GR164099) due to a packaging error that may have resulted in Amlodipine 5 mg Tablets being included in the cartons. Pharmacy and healthcare professionals are advised to return remaining stock to suppliers.

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 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.

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.