MHRA Drug & Device Safety Alerts
Drug safety updates, medicines recalls, device safety information and field safety notices published by the Medicines and Healthcare products Regulatory Agency. Source: MHRA alerts and recalls on GOV.UK.
Erythromycin Oral Suspension – manufacturers certificate withdrawn
Biplane cardiovascular X-ray system (Floor Mounted) - risk of interruption in treatment/procedure
Hydroxyethyl starch (HES) products - increased risk of renal dysfunction and mortality
Biplane cardiovascular X-ray system - risk of interruption in treatment/procedure
Implantable drug pumps and accessories - risk of drug under- or overdose
AmBisome 50mg Powder for Solution for Infusion - potential lack of sterility assurance
Ventolin Syrup sugar-free 2mg in 5ml - risk of glass fragments in the bottles
Questran 4g sachet Powder for Oral Suspension - possible contamination with Enterococcus faecium
Paradigm ambulatory insulin infusion pumps - risk of compromised insulin therapy
Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules - risk of inadequate external pacing
Adrenaline (Epinephrine) Injection 1:10,000 1mg/10ml, Amiodarone Injection 30mg/ml, Ephedrine Hydrochloride Injection 3mg/ml - misalignment of syringe label
Retrievable inferior vena cava (IVC) filters - serious complications associated with attempted IVC filter retrieval
Ativan Injection 4mg/ml - glass particles identified
Diazepam 2mg Tablets - does not comply with the required specification
Miacalcic 200 IU Nasal Spray Solution - withdrawn throughout the European Union
Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces – risk of degrading plastic surfaces
GemStar infusion system - risk of over-infusion, low infusion rates or an interruption of infusion
Circadin 2mg prolonged-release tablets – error in patient information leaflet
ADEPT® 12/14 modular head hip components - higher than expected revision rate
Cytarabine Injection 100mg/ml (1g/10ml) - potential for crystallisation
Montelukast 5 mg Chewable Tablets - error on the carton
Brochlor 1% w/w Eye Ointment – issue with seal integrity and compromised sterility assurance
GoldenEye 0.15% w/w eye ointment – issue with seal integrity and compromised sterility assurance
Desloratadine ratiopharm 5mg film-coated tablets - higher than expected levels of impurities detected
Isoline implantable cardioverter defibrillator (ICD) leads - risk of inappropriate shocking, pacing inhibition or shocking inhibition
Infusion pumps: Plum A+ and A+3 family of infusers - risk of interruption in therapy
Dexamfetamine Sulphate 5mg Tablets – packs may contain 3 blister strips instead of 2
Gygel Contraceptive Jelly – test results did not comply with required specifaction
All medical devices and medicinal products containing chlorhexidine - Risk of anaphylactic reaction due to chlorhexidine allergy
Tredaptive modified-release tablets - withdrawn throughout the European Union
Medical device alert: Sprint Fidelis implantable cardioverter defibrillator (ICD) lead - reports of lead conductor fracture
Medical Device Alert (MDA): the format MHRA used for device alerts until 2021.
Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers) – failure to appropriately decontaminate
Metal-on-metal (MoM) hip replacements - updated advice with patient follow ups
Vimpat 150mg Tablets - blister strips are incorrectly labelled
Zovirax Suspension 200mg/5ml - incorrect dosing instructions
Diflucan powder for oral suspension (10 mg/ml and 40 mg/ml) - amended labels and patient information leaflet
Silicone tracheostomy tubes - eyelets of silicone tracheostomy tubes damaged by holder
Electrosurgical (diathermy) accessories - ensure procedures are in place to check all electrosurgical accessories regularly
Anapen 500mcg, 300mcg and Junior 150mcg/0.3ml solution for injection in a pre-filled syringe
Levothyroxine 100mcg tablets - recall of Teva UK and Numark branded product
Macrolane™ Volume Restoration Factor (VRF) dermal filler for breast augmentation - diagnosis of breast cancer difficult in some cases
Typhim Vi - Typhoid Polysaccharide Vaccine - antigen levels below required specification
SynchroMed® implantable drug pump - consider changing diamorphine for another medicine
Oral swabs with a foam head - heads may detach during use
Rabipur - potential problem packaging of syringes
Epistatus, Midazolam 10mg in 1ml Buccal Liquid x 5ml - packs containing new syringes to be distributed
Silicone gel filled breast implants - updated information on filler
Stapler Duet TRS™ universal straight and articulating single use loading units (SULU) - do not use for adult or paediatric thoracic surgery procedures
Vigantoletten (1000 IU Colecalciferol) Tablets – reminder that tablets contain soya oil
About this source
Read the chart values
| Alert type | Individual alerts |
|---|---|
| Drug Safety Update | 713 |
| Class 1 Medicines Recall | 6 |
| Class 2 Medicines Recall | 159 |
| Class 3 Medicines Recall | 68 |
| Class 4 Medicines Defect Information | 179 |
| Company-Led Medicines Recall | 35 |
| Device Safety Information | 21 |
| Medical Device Alert | 40 |
| National Patient Safety Alert | 11 |
| MHRA Safety Roundup | 16 |
| Unclassified | 253 |
The MHRA regulates medicines and medical devices in the UK and publishes safety communications on GOV.UK in two streams: the monthly Drug Safety Update bulletin, and Alerts and recalls for drugs and medical devices. This page holds 2,267 of those publications, issued between October 2009 and July 2026.
MHRA classes a medicines recall by the hazard the defect presents: Class 1 life-threatening or serious, Class 2 could cause illness or mistreatment, Class 3 unlikely to cause harm, and Class 4 a caution in use rather than a recall, with the product staying available. A device notice is published as Device Safety Information, or, until 2021, as a Medical Device Alert.
What is not here. We hold each publication's title, type, date and link, not its text: read the alert on GOV.UK for the affected products and the actions MHRA asks for. An alert names a medicine or device and a clinical audience, not an organisation, so no alert on this page is linked to an NHS trust or other responsible body. The weekly “Field Safety Notices” pages are MHRA's own index of the notices manufacturers issued that week, not single alerts, and are counted separately above.