MHRA Drug & Device Safety Alerts

Safety alerts, recalls, and field safety notices from the Medicines and Healthcare products Regulatory Agency — covering drug safety updates, medical device alerts, and class recalls.

514

Total Alerts

250

Drug Safety Updates

264

Device Alerts

Alerts by Type

Key Insights

514 MHRA alerts tracked. 250 Drug Safety Updates. 264 Medical Device Alerts.

MHRA alerts link to NHS trusts and healthcare bodies — cross-reference with responsible body scorecard pages to surface patterns between safety alert volumes and inquiry recommendation delivery.

Showing 514 alerts

Class 2 Medicines Recall: ChloraPrep 1mL Clear Sterile Solution/Applicator, Becton Dickinson UK Ltd, EL(25)A/36

class-2-medicines-recall-chloraprep-1ml-clear-sterile-solution-slash-applicator-becton-dickinson-uk- Medical Device Alert

28 Jul 2025 MHRA

Updated guidance on the management of the recalled Endologix Nellix EndoVascular Aneurysm Sealing (EVAS) System (DSI/20…

updated-guidance-on-the-management-of-the-recalled-endologix-nellix-endovascular-aneurysm-sealing-ev Medical Device Alert

28 Jul 2025 MHRA

Class 2 Medicines Recall: Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension , C…

class-2-medicines-recall-flutiform-250-micrograms-slash-10-micrograms-per-actuation-pressurised-inha Medical Device Alert

24 Jul 2025 MHRA

Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), includ…

trinity-biotech-premier-hb9210-hba1c-analyser-risk-of-positive-bias-and-updates-to-instructions-for- Medical Device Alert

22 Jul 2025 MHRA

Field Safety Notices: 14 to 18 July 2025

field-safety-notices-14-to-18-july-2025 Medical Device Alert

22 Jul 2025 MHRA

Field Safety Notices: 7 to 11 July 2025

field-safety-notices-7-to-11-july-2025 Medical Device Alert

21 Jul 2025 MHRA

Field Safety Notices: 30 June to 4 July 2025

field-safety-notices-30-june-to-4-july-2025 Medical Device Alert

08 Jul 2025 MHRA

Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34

class-2-medicines-recall-zaditen-0-dot-25-mg-slash-ml-eye-drops-solution-laboratoires-thea-el-25-a-s Medical Device Alert

07 Jul 2025 MHRA

Abrysvo▼ (Pfizer RSV vaccine) and Arexvy▼ (GSK RSV vaccine): be alert to a small risk of Guillain-Barré syndrome follow…

abrysvov-pfizer-rsv-vaccine-and-arexvyv-gsk-rsv-vaccine-be-alert-to-a-small-risk-of-guillain-barre-s Drug Safety

07 Jul 2025 MHRA

Class 4 Medicines Defect Notification: Simvastatin 10mg Tablet, Crescent Pharma Ltd, EL(25)A/33

class-4-medicines-defect-notification-simvastatin-10mg-tablet-crescent-pharma-ltd-el-25-a-slash-33 Medical Device Alert

03 Jul 2025 MHRA

Field Safety Notices: 23 to 27 June 2025

field-safety-notices-23-to-27-june-2025 Medical Device Alert

02 Jul 2025 MHRA

Class 4 Medicines Defect Notification: Erythromycin Stearate BP 250mg Tablets, Amdipharm UK Ltd, EL(25)A/32

class-4-medicines-defect-notification-erythromycin-stearate-bp-250mg-tablets-amdipharm-uk-ltd-el-25- Medical Device Alert

01 Jul 2025 MHRA

Aurum pre-filled syringes phased introduction of new 10ml CONNECT syringe barrel: Importance of selecting compatible ne…

aurum-pre-filled-syringes-phased-introduction-of-new-10ml-connect-syringe-barrel-importance-of-selec Medical Device Alert

01 Jul 2025 MHRA

Class 3 Medicines Recall: Omeprazole 20 mg/15 ml Oral Solution, Glenmark Pharmaceuticals Europe Ltd, EL(25)A/30

class-3-medicines-recall-omeprazole-20-mg-slash-15-ml-oral-solution-glenmark-pharmaceuticals-europe- Medical Device Alert

30 Jun 2025 MHRA

Class 3 Medicines Recall: Tamoxifen 20mg Film-Coated Tablets, Wockhardt UK Ltd, EL(25)A/31

class-3-medicines-recall-tamoxifen-20mg-film-coated-tablets-wockhardt-uk-ltd-el-25-a-slash-31 Medical Device Alert

30 Jun 2025 MHRA

Class 2 Medicines Recall: Depo-Medrone 80 mg in 2 mL, Maxearn Limited EL(25)A/29

class-2-medicines-recall-depo-medrone-80-mg-in-2-ml-maxearn-limited-el-25-a-slash-29 Medical Device Alert

25 Jun 2025 MHRA

Class 3 Medicines Recall: Kimmtrak 200 micrograms/mL concentrate for solution for infusion, Immunocore Limited, EL(25)A…

class-3-medicines-recall-kimmtrak-200-micrograms-slash-ml-concentrate-for-solution-for-infusion-immu Medical Device Alert

25 Jun 2025 MHRA

Field Safety Notices: 16 to 20 June 2025

field-safety-notices-16-to-20-june-2025 Medical Device Alert

24 Jun 2025 MHRA

MHRA Safety Roundup: June 2025

mhra-safety-roundup-june-2025 Medical Device Alert

24 Jun 2025 MHRA

Field Safety Notices: 9 to 13 June 2025

field-safety-notices-9-to-13-june-2025 Medical Device Alert

17 Jun 2025 MHRA

MHRA Safety Roundup: May 2025

mhra-safety-roundup-may-2025 Medical Device Alert

13 Jun 2025 MHRA

Class 2 Medicines Recall: Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited, EL(25)A/27

class-2-medicines-recall-inhixa-12000iu-120mg-slash-0-dot-8ml-solution-for-injection-maxearn-limited Medical Device Alert

12 Jun 2025 MHRA

Field Safety Notices: 2 to 6 June 2025

field-safety-notices-2-to-6-june-2025 Medical Device Alert

10 Jun 2025 MHRA

Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼):…

valproate-belvo-convulex-depakote-dyzantil-epilim-epilim-chrono-or-chronosphere-episenta-epival-and- Drug Safety

10 Jun 2025 MHRA

Class 4 Medicines Defect Notification: Dulcolax Adult 5 mg Gastro-resistant Tablets, Opella Healthcare UK, EL(25)A/26

class-4-medicines-defect-notification-dulcolax-adult-5-mg-gastro-resistant-tablets-opella-healthcare Medical Device Alert

10 Jun 2025 MHRA

Class 2 Medicines Recall: Paracetamol 500mg Tablets, Chelonia Healthcare Limited, EL(25)A/25

class-2-medicines-recall-paracetamol-500mg-tablets-chelonia-healthcare-limited-el-25-a-slash-25 Medical Device Alert

09 Jun 2025 MHRA

Field Safety Notices: 19 to 23 May 2025

field-safety-notices-19-to-23-may-2025 Medical Device Alert

06 Jun 2025 MHRA

Field Safety Notices: 26 to 30 May 2025

field-safety-notices-26-to-30-may-2025 Medical Device Alert

03 Jun 2025 MHRA

Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various Products, EL(25)A/24

class-4-medicines-notification-zentiva-pharma-uk-limited-various-products-el-25-a-slash-24 Medical Device Alert

02 Jun 2025 MHRA

Philips Respironics BiPAP A series ventilators: alarm malfunction and risk of therapy interruptions in ventilators not …

philips-respironics-bipap-a-series-ventilators-alarm-malfunction-and-risk-of-therapy-interruptions-i Medical Device Alert

23 May 2025 MHRA

Class 2 Medicines Recall: Mercaptopurine 50mg Tablets, Aspen Pharma Trading Limited, EL (25)A/23

class-2-medicines-recall-mercaptopurine-50mg-tablets-aspen-pharma-trading-limited-el-25-a-slash-23 Medical Device Alert

22 May 2025 MHRA

Field Safety Notices: 12 to 16 May 2025

field-safety-notices-12-to-16-may-2025 Medical Device Alert

20 May 2025 MHRA

Class 2 Medicines Recall: BD ChloraPrep Clear - 1mL Applicator, Becton Dickinson UK Ltd, EL(25)A/22

class-2-medicines-recall-bd-chloraprep-clear-1ml-applicator-becton-dickinson-uk-ltd-el-25-a-slash-22 Medical Device Alert

19 May 2025 MHRA

Thiopurines and intrahepatic cholestasis of pregnancy

thiopurines-and-intrahepatic-cholestasis-of-pregnancy Drug Safety

15 May 2025 MHRA

Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products, EL(25)A/21

class-4-medicines-notification-chemidex-pharma-ltd-various-products-el-25-a-slash-21 Medical Device Alert

13 May 2025 MHRA

Class 4 Medicines Defect Notification: Chloramphenicol 1% w/w Eye Ointment, Blumont Pharma Limited, EL(25)A/20

class-4-medicines-defect-notification-chloramphenicol-1-percent-w-slash-w-eye-ointment-blumont-pharm Medical Device Alert

08 May 2025 MHRA

Field Safety Notices: 28 October to 1 November 2024

field-safety-notices-28-october-to-1-november-2024 Medical Device Alert

08 May 2025 MHRA

Kaftrio▼ (Ivacaftor, tezacaftor, elexacaftor): risk of psychological side effects

kaftriov-ivacaftor-tezacaftor-elexacaftor-risk-of-psychological-side-effects Drug Safety

07 May 2025 MHRA

Field Safety Notices: 28 April to 2 May 2025

field-safety-notices-28-april-to-2-may-2025 Medical Device Alert

06 May 2025 MHRA

MHRA Safety Roundup: April 2025

mhra-safety-roundup-april-2025 Medical Device Alert

29 Apr 2025 MHRA

Class 4 Medicines Defect Notification: Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules, Jubilan…

class-4-medicines-defect-notification-pregabalin-25mg-50mg-75mg-100mg-150mg-200mg-225mg-300mg-capsul Medical Device Alert

29 Apr 2025 MHRA

Field Safety Notices: 14 to 18 April 2025

field-safety-notices-14-to-18-april-2025 Medical Device Alert

25 Apr 2025 MHRA

Short-acting beta 2 agonists (SABA) (salbutamol and terbutaline): reminder of the risks from overuse in asthma and to b…

short-acting-beta-2-agonists-saba-salbutamol-and-terbutaline-reminder-of-the-risks-from-overuse-in-a Drug Safety

24 Apr 2025 MHRA

Class 2 Medicines Recall: Lercanidipine HCl 20mg Tablets, Recordati Industria, EL(25)A/17

class-2-medicines-recall-lercanidipine-hcl-20mg-tablets-recordati-industria-el-25-a-slash-17 Medical Device Alert

17 Apr 2025 MHRA

Field Safety Notices: 7 to 11 April 2025

field-safety-notices-7-to-11-april-2025 Medical Device Alert

15 Apr 2025 MHRA

Fezolinetant▼(Veoza): risk of liver injury; new recommendations to minimise risk

fezolinetantv-veoza-risk-of-liver-injury-new-recommendations-to-minimise-risk Drug Safety

10 Apr 2025 MHRA

Class 2 Medicines Recall: Synalar GEL 30g, Synalar GEL 60g,(fluocinolone acetonide 0.025%) Reig Jofre UK,EL(25)A/16

class-2-medicines-recall-synalar-gel-30g-synalar-gel-60g-fluocinoline-acetonide-0-dot-025-percent-re Medical Device Alert

08 Apr 2025 MHRA

Field Safety Notices: 31 March to 4 April 2025

field-safety-notices-31-march-to-4-april-2025 Medical Device Alert

08 Apr 2025 MHRA

MHRA Safety Roundup: March 2025

mhra-safety-roundup-march-2025 Medical Device Alert

08 Apr 2025 MHRA

Class 4 Medicines Defect Notification: Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare NephroMed GmbH, EL…

class-4-medicines-defect-notification-renacet-475-mg-and-950-mg-tablets-calcium-acetate-renacare-nep Medical Device Alert

07 Apr 2025 MHRA