MHRA Safety Roundup: April 2026

Summary of the latest safety advice for medicines and medical device users

• From: Medicines and Healthcare products Regulatory Agency
• Published: 29 April 2026

• Message type: MHRA Safety Roundup
• Medical specialty: Anaesthetics and intensive care, Breastfeeding, Cancer, Cardiovascular disease and lipidology and Care home staff
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  Cosmetic surgery, Critical care, Dentistry, Dermatology, Dispensing GP practices, Ear, nose and throat, Emergency medicine, Endocrinology, diabetology and metabolism, General practice, General surgery, GI, hepatology and pancreatic disorders, Haematology and oncology, Immunology and vaccination, Immunosuppression and transplantation, Infection prevention, Infectious disease, Neurology, Nutrition and dietetics, Obstetrics & gynaecology and fertility, Ophthalmology, Orthopaedics, Paediatrics and neonatology, Pain management and palliation, Pathology, Pharmacy, Physiotherapy and occupational therapy, Pregnancy, Psychiatry, Radiology and imaging, Renal medicine, Respiratory disease and allergy, Rheumatology, Theatre practitioners, Urology and nephrology, and Vascular and cardiac surgery
• Issued: 29 April 2026

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MHRA Safety Roundup: April 2026

Please access the PDF version of our Safety Roundup for our easy-read template and QR codes to access the full articles.

Letters, medicines recalls and device notifications sent to healthcare professionals in April 2026 

Direct Healthcare Professional Communications 

We received notification that the following Direct Healthcare Professional Communications were sent or provided to relevant healthcare professionals in April 2026:

• Trumenba 60 µg/dose suspension for injection (meningococcal group B vaccine (recombinant, adsorbed) - Provision of packs in foreign language

• Sodium Chloride 0.9% solution for infusion(PL 08828/0084): Interim Supply of USA Labelled Stock to Mitigate Supply Disruption

• Potential particulates in certain Visipaque (Iodixanol) and Omnipaque (Iohexol) 100 ml polymer bottles

• Aurum pre-filled syringes: instructions to ensure box end labels are intact prior to use

• Enzalutamide Astellas 40mg film-coated tablet: enzalutamide laboratory test interference leading to falsely elevated digoxin plasma levels

• Methylphenidate hydrochloride: Supply of Meflynate XL 10 mg, 20 mg, 40 mg & 60 mg modified-release hard capsules with blisters strips printed with Spanish labelling. Sent to relevant stakeholders in March 2026.

• Imatinib Accord 100mg and 400 mg film coated tablets (imatinib) - Missing safety information in the Patient Information Leaflet (PIL). Sent to relevant stakeholders in March 2026.

Medicine Recalls and Notifications

In April 2026, recalls and notifications for medicines were issued on:

Class 2 Medicines Recall: Amarox Limited, Sertraline 100mg film-coated tablets, EL(26)A/22. Issued 28 April 2026

Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site.

Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 10mg capsules, EL(26)A/19. Issued 20 April 2026.

Crescent Pharma Limited is recalling one batch of Ramipril 10mg Capsules as a precautionary measure due to a potential error at the manufacturing site.

Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21. Issued 23 April 2026.

Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet (PIL) and on the Carton in packs of Napralief 250mg Gastro-resistant tablets.

Class 4 Medicines Recall: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20. Issued 22 April 2026.

Doncaster Pharma Limited has informed the MHRA of an error related to the Braille embossing on the outer packaging of certain parallel imported batches of Hiprex 1 g tablets (POM).

 Medical Device Field Safety Notices 

Find recently published Field Safety Notices 

Report suspected drug reactions and device incidents on a Yellow Card

Please continue to report suspected adverse drug reactions and device incidents. Your report will help us safeguard public health. 

When reporting, please provide as much information as possible, including information about medical history, any concomitant medication, onset timing, treatment dates and particularly if a side effect continued or started after treatment was stopped. 

Report a medicine

Healthcare professionals should report via a Yellow Card to: 

• the Yellow Card website
• the Yellow Card app; download from the Apple App Store or Google Play Store
• some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses) 

Reporting for medical devices 

Healthcare professionals should report incidents: 

• in England and Wales to the Yellow Card website or via the Yellow Card app
• in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
• in Northern Ireland to the Yellow Card website in accordance with your organisation’s medical device policies and procedures

Reporting for patients 

Patients should report via a Yellow Card to: 

• the Yellow Card website 
• the Yellow Card app; download from the Apple App Store or Google Play Store 

News Roundup

EMA recommends withdrawal of marketing authorisations for levamisole medicines following safety review

In February 2026, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) issued a recommendation that medicines containing levamisole be withdrawn from the EU market following a safety review confirming leukoencephalopathy as a rare but serious side effect. This follows an EU-wide review which concluded that the benefits of these medicines no longer outweigh their risks for the treatment of parasitic infections in adults and children.

Levamisole is a medicine licenced in the EU and indicated for the treatment of mild parasitic infections in adults and children, and is also thought to be a mild immunosuppressant. Levamisole does not hold a current UK marketing authorisation however, levamisole containing medicines are used in the UK off-label in exceptional circumstances to treat children with frequently relapsing or steroid-dependent nephrotic syndrome, to help maintain remission and lower the steroid dosage.

Publication of RSV vaccine factsheet

The MHRA has published a new RSV vaccine factsheet, designed to provide information and guidance for patients, parents and carers about respiratory syncytial virus (RSV), and the vaccines used to protect people at higher risk of serious illness.

The factsheet covers what RSV is, who is eligible for vaccination in the UK, and the safety and effectiveness of RSV vaccines, including information on side effects and vaccination during pregnancy.

This resource is now available for healthcare professionals, patients and the public. For more information, view the full RSV Vaccine Factsheet – Information for Patients, Parents and Carers.

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Published 29 April 2026