Class 3 Medicines Recall: Theramex Ireland Ltd T/A Theramex HQ UK Ltd, AlfaD 0.25 microgram capsules (PL 49876/0001), EL (20) A/50
MHRA class: the defect is unlikely to cause harm; recall is on other grounds.
Source · Drug & device safety alerts
MHRA Drug & Device Safety Alerts
1,501 individual alerts
447 medicines recalls & defect notices
766 weekly / monthly index pages
Oct 2009 – Jul 2026
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.
Showing 2,267 publications of 2,267
Field Safety Notice: 19 to 23 October
A weekly index of the field safety notices manufacturers issued that week.
Every report counts: report suspected adverse drug reactions and take part in #MedSafetyWeek (2–8 November 2020)
An article in MHRA's monthly Drug Safety Update bulletin.
Warfarin and other anticoagulants: monitoring of patients during the COVID-19 pandemic
An article in MHRA's monthly Drug Safety Update bulletin.
Niraparib (Zejula▼): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment
An article in MHRA's monthly Drug Safety Update bulletin.
Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): updated advice on increased risk of neural tube defects
An article in MHRA's monthly Drug Safety Update bulletin.
5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity
An article in MHRA's monthly Drug Safety Update bulletin.
Flucytosine (Ancotil): new contraindication in patients with DPD deficiency
An article in MHRA's monthly Drug Safety Update bulletin.
Letters and drug alerts sent to healthcare professionals in September 2020
A periodic index page listing other alerts and letters, not a single alert.
Company led drug alert - Optiray® 300mg I/ml Solution for Injection or Infusion (PL 12308/0028) and Optiray® 350mg I/ml Solution for Injection or Infusion (PL 12308/0032)
A recall the marketing authorisation holder initiated, published by MHRA.
Field Safety Notice: 12 to 16 October
A weekly index of the field safety notices manufacturers issued that week.
Medical Devices Safety Bulletin (MDSB/2020/01)
Class 2 Medicines Recall: Sanofi Epilim 500mg Gastro-Resistant Tablets EL (20)A/48*
MHRA class: the defect could cause illness or mistreatment, but is not Class 1.
Class 3 Medicines Recall: Metoprolol 50 mg Tablets (PL 20075/0304), EL (20)A/49
MHRA class: the defect is unlikely to cause harm; recall is on other grounds.
Field Safety Notices: 5 to 9 October 2020
A weekly index of the field safety notices manufacturers issued that week.
Class 2 Medicines Recall: Boots Dermacare 1% w/w Hydrocortisone Ointment (Batch 1DD), EL (20)A/47
MHRA class: the defect could cause illness or mistreatment, but is not Class 1.
Field Safety Notices: 28 September to 02 October 2020
A weekly index of the field safety notices manufacturers issued that week.
Class 3 Medicines Recall: Theramex Ireland Ltd T/A Theramex HQ UK Ltd, AlfaD Capsules, EL (20) A/46
MHRA class: the defect is unlikely to cause harm; recall is on other grounds.
Field Safety Notice: 21 to 26 September 2020
A weekly index of the field safety notices manufacturers issued that week.
Field Safety Notice: 12 to 16 August 2019
A weekly index of the field safety notices manufacturers issued that week.
Letters and drug alerts sent to healthcare professionals in August 2020
A periodic index page listing other alerts and letters, not a single alert.
Insulins (all types): risk of cutaneous amyloidosis at injection site
An article in MHRA's monthly Drug Safety Update bulletin.
Transdermal fentanyl patches for non-cancer pain: do not use in opioid-naive patients
An article in MHRA's monthly Drug Safety Update bulletin.
Opioids: risk of dependence and addiction
An article in MHRA's monthly Drug Safety Update bulletin.
Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing
An article in MHRA's monthly Drug Safety Update bulletin.
National Patient Safety Alert: Philips Respironics V60 ventilator - unexpected shutdown (NatPSA/2020/007/MHRA)
A National Patient Safety Alert requires named actions from NHS providers.
Field Safety Notices: 14 to 18 September 2020
A weekly index of the field safety notices manufacturers issued that week.
Class 2 FMD Medicines Recall, Parallel Distributed Medicines, Multiple Products, EL (20)A/45
MHRA class: the defect could cause illness or mistreatment, but is not Class 1.
Field Safety Notices: 7 to 11 September 2020
A weekly index of the field safety notices manufacturers issued that week.
Class 4 Medicines Defect Information: Zopiclone Tablets, Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan, EL (20)A/44
MHRA class: a minor defect; the product stays available with a caution in use, not a recall.
Class 3 Medicines Recall: Accord Healthcare Limited, Amlodipine 10mg Tablets
MHRA class: the defect is unlikely to cause harm; recall is on other grounds.
Field Safety Notices: 1 to 4 September 2020
A weekly index of the field safety notices manufacturers issued that week.
Class 2 Medicines Recall: GL Pharma GmbH, Oxylan 40mg prolonged-release tablets, EL (20)A/41
MHRA class: the defect could cause illness or mistreatment, but is not Class 1.
Class 4 FMD Medicines Information: WDA(H) 49276 Kingsley Specials Ltd, Multiple Products, (EL (20)A/42)
MHRA class: a minor defect; the product stays available with a caution in use, not a recall.
Medical Device Alerts issued in July 2020
A periodic index page listing other alerts and letters, not a single alert.
Letters and drug alerts sent to healthcare professionals in July 2020
A periodic index page listing other alerts and letters, not a single alert.
Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment
An article in MHRA's monthly Drug Safety Update bulletin.
Baricitinib (Olumiant▼): increased risk of diverticulitis, particularly in patients with risk factors
An article in MHRA's monthly Drug Safety Update bulletin.
Isotretinoin (Roaccutane▼): reminder of important risks and precautions
An article in MHRA's monthly Drug Safety Update bulletin.
Clozapine and other antipsychotics: monitoring blood concentrations for toxicity
An article in MHRA's monthly Drug Safety Update bulletin.
Update: Wockhardt UK Ltd - Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection
Class 2 Medicines Recall: Sanofi Fasturtec 7.5 mg, 1.5 mg/ml powder and solvent for concentrate for solution for infusion, EL (20)A/40
MHRA class: the defect could cause illness or mistreatment, but is not Class 1.
Field Safety Notices: 17 - 21August 2020
A weekly index of the field safety notices manufacturers issued that week.
Stimulant laxatives (bisacodyl, senna and sennosides, sodium picosulfate) available over-the-counter: new measures to support safe use
An article in MHRA's monthly Drug Safety Update bulletin.
Field Safety Notices: 10 - 14 August 2020
A weekly index of the field safety notices manufacturers issued that week.
Class 4 Medicines Defect Information: SmofKabiven extra Nitrogen Electrolyte Free, EL (20)A/39, PL 08828/0269
MHRA class: a minor defect; the product stays available with a caution in use, not a recall.
Class 2 Medicines Recall: Huddersfield Pharmacy Specials MS 19055, Phosphates Solution for Infusion 500ml, EL (20)A/38
MHRA class: the defect could cause illness or mistreatment, but is not Class 1.
Field Safety Notices - 31 July - 07 August 2020
A weekly index of the field safety notices manufacturers issued that week.
Class 2 Medicines Recall: Pharmaram Ltd, Clexane 4,000 IU (40mg)/0.4ml Syringes, EL (20)A/37
MHRA class: the defect could cause illness or mistreatment, but is not Class 1.
Class 3 Medicines Recall: Accord-UK Ltd, Digoxin Tablets BP 250 micrograms, EL (20)A/35
MHRA class: the defect is unlikely to cause harm; recall is on other grounds.
About this source
Individual alerts by type
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.