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Letters, medicines recalls and device notifications sent to healthcare professionals inÌýApril 2026Ìý

Direct Healthcare Professional CommunicationsÌý

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

• . Sent to relevant stakeholders in March 2026.

• . Sent to relevant stakeholders in March 2026.

Medicine Recalls and Notifications

InÌýApril 2026,Ìýrecalls 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).

ÌýMedical Device Field Safety NoticesÌý

Find recently published Field SafetyÌýNoticesÌý

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.Ìý

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.Ìý

Report a medicine

Healthcare professionals should report via a Yellow Card to:Ìý

• ³Ù³ó±ð 
• theÌýYellow Card app; download from ³Ù³ó±ð  o°ù 
• someÌýclinical IT systems for healthcare professionals (EMIS,ÌýSystmOne, Vision,ÌýMiDatabank, and Ulysses)Ìý

Reporting for medical devicesÌý

Healthcare professionals should report incidents:Ìý

• inÌýEngland and Wales to the or via the Yellow Card app
• inÌýScotland to and their local incident recording system
• inÌýNorthern Ireland to theÌýYellow Card websiteÌýin accordance withÌýyour organisation’s medical device policies and procedures

Reporting for patientsÌý

Patients should report via a Yellow Card to:Ìý

• theÌýÌý
• theÌýYellow Card app; download from ³Ù³ó±ð  o°ù Ìý

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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