Patient safety information
Published on: 27th July 2017 | Updated on: 19th December 2024
The Medicines and Healthcare products Regulatory Agency (MHRA) have made changes to the way they issue drug safety messaging to healthcare providers.
MHRA Drug Alerts have been renamed, drug safety notices will no longer be referred to as ‘Drug alerts’ and ‘company led Drug alerts’ for any MHRA safety message which does not meet the criteria of a National Patient Safety Alert. These have now been replaced by ‘Medicines recall/notification’, which will have the same layout and format as previous ‘alerts’. All Class 1 Medicines Recalls will meet the National Patient Safety Alert criteria and will be issued as National Patient Safety Alerts (NatPSA).
A table explaining the new Medicines Recall and Notification classifications and the associated defect risk classification can be found on the gov.uk website.
Changes to titles
| Previous title | New title |
| Drug Alert: Class 1 | National Patient Safety Alert (NatPSA)(equivalent to Class 1 Medicines Recall) |
| Drug Alert: Class 2-4 | Medicines Recall: Class 2-3 |
| Drug Alert: Caution in Use, Class 4 | Medicines Notification: Caution in use, Class 4 |
| Company-Led Drug Alert | Company-Led Medicines Recall/Notification |
This page contains a list of:
- patient safety notifications (previously referred to as alerts and recalls) which have previously been highlighted as news stories on the Community Pharmacy England website;
- advice and guidance relating to patient safety which have previously been highlighted as news stories on the Community Pharmacy England website; and
- a link to the MHRA monthly drug safety updates.
Although pharmacy teams should have responded as appropriate to the above within the required time frames, those that have been highlighted as news stories on the Community Pharmacy England website have been listed on this page as a quick reference for pharmacy teams to check that they are aware of all of the published notices and have taken appropriate action, where required.
As relevant news stories are published on the Community Pharmacy England website they will be added to the lists below.
| Date issued | Recall/Notification type | Medicines recall/notification |
| 19th December 2024 | MHRA Class 4 Medicines Defect Information | |
| 18th December 2024 | National Patient Safety Alert – DHSC |
Shortage of Pancreatic enzyme replacement therapy (PERT) – Additional actions |
| 9th December 2024 | MHRA Class 2 Medicines Recall |
WockAIR 160 microgram/4.5 microgram, inhalation powder (Wockhardt UK Limited) |
| 4th December 2024 | MHRA Class 4 Medicines Defect Information |
Oxybutynin hydrochloride 2.5 mg/5 ml Oral Solution (Brillpharma Limited) |
| 3rd December 2024 | MHRA Class 3 Medicines Recall |
Phenoxymethylpenicillin 250mg/5ml Oral Solution Sugar Free (Kent Pharma UK) |
| 2nd December 2024 | MHRA Class 4 Medicines Defect Information |
Mycophenolate Mofetil 1g/5ml Oral Suspension (Rosemont Pharmaceuticals Limited) |
| 28th November 2024 | MHRA Class 4 Medicines Defect Information |
Liothyronine Sodium 5 & 20 micrograms Tablets (Strides Pharma UK Ltd) |
| 27th November 2024 | MHRA Class 4 Medicines Defect Information | |
| 25th November 2024 | MHRA Class 3 Medicines Recall | |
| 12th November 2024 | MHRA Class 4 Medicines Defect Information |
Omeprazole 40mg Powder for solution for infusion (Viatris UK Healthcare Ltd) |
| 7th November 2024 | MHRA Class 4 Medicines Defect Information |
Zoledronic Acid Ennogen 4mg/5ml concentrate for solution for infusion (Ennogen Healthcare Limited) |
| 29th October 2024 | MHRA Class 2 Medicines Recall | |
| 28th October 2024 | MHRA Class 4 Medicines Defect Information |
Parasolve (Paracetamol) 500mg effervescent tablets (Kent Pharma UK) |
| 24th October 2024 | MHRA Class 3 Medicines Recall | |
| 23rd October 2024 | MHRA Class 2 Medicines Recall |
Phenobarbital Bristol Labs 15mg Tablets (Bristol Laboratories Ltd) |
| 21st October 2024 | National Patient Safety Alert |
Discontinuation of Kay-Cee-L® (potassium chloride 375mg/5ml) (potassium chloride 5mmol/5ml) syrup |
| 21st October 2024 | MHRA Class 4 Medicines Defect Information | |
| 10th October 2024 | MHRA Class 4 Medicines Defect Information | |
| 7th October 2024 | MHRA Class 3 Medicines Recall |
Trandolapril 2mg and 4mg capsules (Viatris UK Healthcare Ltd) |
| 3rd October 2024 | MHRA Class 3 Medicines Recall |
Cyanocobalamin 50 mcg Tablets (Glenmark Pharmaceuticals Europe Ltd) |
| 1st October 2024 | MHRA Class 4 Medicines Defect Information | |
| 30th September 2024 | MHRA Class 2 Medicines Recall |
Medicines Recall: Oxbryta (voxelotor) 500mg Tablets (Pfizer Limited) |
| 26th September 2024 | MHRA Class 4 Medicines Defect Information |
Risperidone 1mg, 2mg, 3mg tablets (Sandoz Ltd) |
| 18th September 2024 | MHRA Class 3 Medicines Recall | |
| 12th September 2024 | MHRA Class 3 Medicines Recall | |
| 27th August 2024 | MHRA Class 4 Medicines Defect Information |
Ponstan 250mg Capsules & 500mg Tablets (Chemidex Pharma Ltd) |
| 19th August 2024 | MHRA Class 3 Medicines Recall |
Fingolimod 0.5 mg Hard Capsules (Glenmark Pharmaceuticals Europe Ltd) |
| 15th August 2024 | MHRA Class 2 Medicines Recall |
Loperamide Hydrochloride Capsules 2mg (Strides Pharma UK Limited) |
| 14th August 2024 | MHRA Class 4 Medicines Defect Information |
Trazodone Hydrochloride 50mg, 100mg Capsules & 50mg/5ml Oral Solution (Dawa Limited) |
| 12th August 2024 | MHRA Class 4 Medicines Defect Information |
Diflucan Oral Suspension 40mg/ml (Star Pharmaceuticals Limited) |
| 8th August 2024 | MHRA Class 3 Medicines Recall | |
| 7th August 2024 | MHRA Class 4 Medicines Defect Information | |
| 30th July 2024 | MHRA Class 3 Medicines Recall | |
| 25th July 2024 | MHRA Class 4 Medicines Defect Information |
Co-trimoxazole 80mg/400mg per 5ml adult suspension (Aspen Pharma Trading Limited) |
| 15th July 2024 | MHRA Class 2 Medicines Recall |
Loperamide Hydrochloride Capsules 2mg (Strides Pharma UK Limited) |
| 9th July 2024 | MHRA Class 4 Medicines Defect Information |
Propantheline Tablets 15mg (Genesis Pharmaceuticals livery (Chelonia Healthcare Limited)) |
| 4th July 2024 | MHRA Class 2 Medicines Recall | |
| 2nd July 2024 | MHRA Class 3 Medicines Recall |
Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules (Accord Healthcare Ltd) |
| 24th June 2024 | MHRA Class 4 Medicines Defect Information | |
| 18th June 2024 | MHRA Class 3 Medicines Recall | |
| 17th June 2024 | MHRA Class 4 Medicines Defect Information |
Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets (Mylan) |
| 10th June 2024 | MHRA Class 4 Medicines Defect Information |
Paracetamol 500mg, 1000mg film coated tablets (Dawa Limited) |
| 3rd June 2024 | MHRA Class 4 Medicines Defect Information |
Betamethasone Valerate 0.1% Ointment (Manx Healthcare Ltd)
|
| 20th May 2024 | MHRA Class 4 Medicines Defect Information | Trazodone hydrochloride 50mg/5ml oral solution (Cygnus Pharma Ltd) |
| 15th May 2024 | MHRA Class 4 Medicines Defect Information | Keppra 500mg film-coated tablets (Doncaster Pharma Limited) |
| 10th April 2024 | MHRA Class 3 Medicines Recall | Co-Codamol 8/500mg Effervescent tablets (Accord-UK Ltd (Key Pharmaceuticals Livery)) |
| 19th March 2024 | MHRA Class 3 Medicines Recall | Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol) (Besins Healthcare (UK) Ltd) |
| 26th February 2024 | MHRA Class 4 Medicines Defect Information | Concerta® XL 18mg & 36 mg prolonged release tablets (Orifarm UK Ltd) |
| 26th February 2024 | National Patient Safety Alert – DHSC | Shortage of salbutamol 2.5mg/2.5ml and 5mg/2.5ml nebuliser liquid unit dose vials |
| 15th February 2024 | MHRA Class 3 Medicines Recall | Ramipril 1.25mg tablets (Torrent Pharma (UK) Limited) |
| 30th January 2024 | MHRA Class 4 Medicines Defect Information | Pantoprazole 40 mg gastro-resistant tablets (Cadila Pharmaceuticals (UK) Limited) |
| 4th January 2024 | MHRA Class 4 Medicines Defect Information | Cozaar® 100mg film-coated tablets (Quadrant Pharmaceuticals Ltd) |
| 6th December 2023 | MHRA Class 4 Medicines Defect Information | Clarithromycin 250mg and 500mg tablets (Strandhaven Ltd t/a Somex Pharma Ltd) |
| 6th December 2023 | MHRA Class 4 Medicines Defect Information | Tramadol Hydrochloride 50mg capsules (Strandhaven Ltd t/a Somex Pharma Ltd) |
| 30th November 2023 | MHRA Class 3 Medicines Recall | Fluenz® Tetra nasal spray suspension (AstraZeneca UK Ltd) |
| 23rd October 2023 | MHRA Class 4 Medicines Defect Information | Zinacef powder for solution for injection or infusion vials (Sandoz Limited) |
| 27th September 2023 | MHRA Class 4 Medicines Defect Information | Max Healthcare Paracetamol 500 mg Capsules (Max Remedies Ltd) |
| 27th September 2023 | National Patient Safety Alert – DHSC | Shortage of methylphenidate prolonged-release capsules and tablets, lisdexamfetamine capsules, and guanfacine prolonged-release tablets |
| 20th September 2023 | MHRA Class 3 Medicines Recall | Trimbow 87/5/9mcg pressurised inhalation solution |
| 7th September 2023 | MHRA Class 4 Medicines Defect Information | Duraphat 5000ppm Fluoride Toothpaste |
| 5th September 2023 | MHRA Class 3 Medicines Recall | Evorel Sequi |
| 30th August 2023 | MHRA Class 2 Medicines Recall | Epistatus 2.5 mg oromucosal solution, pre-filled syringe (PFS) (Veriton Pharma Limited) |
| 29th August 2023 | MHRA Class 4 Medicines Defect Information | |
| 23rd August 2023 | MHRA Class 4 Medicines Defect Information | Olmesartan Medoxomil 10mg & 20mg film coated tablets (Accord Healthcare Limited UK) |
| 31st July 2023 | MHRA Class 2 Medicines Recall | Various Products (B.Braun Medical Ltd) |
| 19th July 2023 | Company Led Medicines Recall | Diltiazem HCl 2% Cream [unlicensed medicine] – Quantum Pharmaceutical |
| 13th July 2023 | MHRA Class 2 Medicines Recall | Sabril 500mg film-coated tablets and 500mg granules for oral solution |
| 10th July 2023 | MHRA Class 2 Medicines Recall | Labetalol 200mg tablets (Tillomed Laboratories Ltd) |
| 23rd May 2023 | MHRA Class 4 Medicines Defect Information | Metronidazole 200mg/5ml oral suspension |
| 22nd May 2023 | MHRA Class 4 Medicines Defect Information | Buccolam 10mg oromucosal solution |
| 9th May 2023 | National Patient Safety Alert: Class 1 Medicines Recall Notification | Emerade 500 micrograms and Emerade 300 micrograms auto-injectors |
| 26th April 2023 | MHRA Class 4 Medicines Defect Information | Beconase Hayfever nasal spray |
| 20th April 2023 | MHRA Class 4 Medicines Defect Information | Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension (Sandoz Limited) |
| 23rd March 2023 | MHRA Class 2 Medicines Recall | GONAPEPTYL Depot 3.75mg powder and solvent for suspension for injection (Ferring Pharmaceuticals Limited) |
| 21st March 2023 | MHRA Class 3 Medicines Recall | Sildenafil 10mg/ml Oral Suspension (Rosemont Pharmaceuticals Ltd) |
| 16th March 2023 | MHRA Class 4 Medicines Defect Information | Venlafaxine XL 150mg, 225mg, 300mg prolonged-release tablets |
| 14th March 2023 | MHRA Class 2 Medicines Recall | Pholcodine-containing products |
| 9th March 2023 | MHRA Class 4 Medicines Defect Information | Clexane 10,000 IU (100mg) / 1ml Syringes (Star Pharmaceuticals Ltd) |
| 7th March 2023 | MHRA Class 4 Medicines Defect Information | Methadone 1mg/mL Oral Solution BP – Sugar Free, Methadone Mixture 1mg/ml |
| 2nd March 2023 | MHRA Class 2 Medicines Recall | Levothyroxine 12.5mcg Tablets (Teva UK Limited) |
| 27th February 2023 | MHRA Class 4 Medicines Defect Information | Zestoretic 20mg/12.5mg Tablets |
| 22nd February 2023 | MHRA Class 4 Medicines Defect Information | Lemsip Max Cold and Flu Capsules (Reckitt Benckiser Healthcare (UK) Limited) |
| 18th January 2023 | MHRA Class 2 Medicines Recall | Dioctyl 100 mg Capsules (UCB Pharma Ltd) |
| 3rd January 2023 | MHRA Class 4 Medicines Defect Information | Bylvay 1200 micrograms Hard Capsules (Albireo AB) |
| 19th December 2022 | MHRA Class 4 Medicines Defect Information | Epiduo 0.1% / 2.5% gel (Galderma (U.K.) Limited) |
| 6th December 2022 | MHRA Class 4 Medicines Defect Information | Etrivex 500 micrograms/g Shampoo (Galderma (U.K.) Limited) |
| 5th December 2022 | MHRA Class 4 Medicines Defect Information | MacroBID 100mg Prolonged-Release Capsules |
| 29th November 2022 | MHRA Class 4 Medicines Defect Information | |
| 21st November 2022 | MHRA Class 4 Medicines Defect Information | |
| 16th November 2022 | MHRA Class 4 Medicines Defect Information | |
| 27th October 2022 | MHRA Class 3 Medicines Recall | |
| 20th October 2022 | National Patient Safety Alert: Class 1 Medicines Recall Notification |
Targocid 200mg powder for solution for injection/infusion or oral solution |
| 20th October 2022 | MHRA Class 2 Medicines Recall | |
| 12th October 2022 | MHRA Class 4 Medicines Defect Information |
Ibuprofen 400mg Tablets, Paracetamol 500mg Tablets (Caplets) |
| 10th October 2022 | MHRA Class 2 Medicines Recall | Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion |
| 6th October 2022 | MHRA Class 2 Medicines Recall | Stemetil 5mg/5ml Syrup |
| 20th September 2022 | MHRA Class 2 Medicines Recall | |
| 14th September 2022 | MHRA Class 4 Medicines Defect Information |
Atorvastatin 4mg/ml Oral Suspension & Sildenafil 10mg/ml Oral Suspension |
| 12th September 2022 | MHRA Class 4 Medicines Defect Information |
Bezalip Mono 400mg Tablets (Quadrant Pharmaceuticals Limited) |
| 22nd August 2022 | Class 2 Medicines Recall | |
| 4th August 2022 | National Patient Safety Alert: Class 1 Medicines Recall Notification |
Mexiletine hydrochloride 50mg, 100mg & 200 mg Hard Capsules (Clinigen Healthcare Ltd) |
| 1st June 2022 | MHRA Class Medicines Defect Information | |
| 17th May 2022 | MHRA Class 2 Medicines Recall | |
| 5th May 2022 | MHRA Class 2 Medicines Recall | |
| 27th April 2022 | MHRA Class 2 Medicines Recall | |
| 11th April 2022 | MHRA Class 2 Medicines Recall | |
| 28th March 2022 | MHRA Class 2 Medicines Recall | |
| 15th March 2022 | MHRA Class 4 Medicines Defect Information | |
| 14th March 2022 | MHRA Class 4 Medicines Defect Information | |
| 7th March 2022 | MHRA Class 2 Medicines Recall | |
| 2nd March 2022 | MHRA Class 3 Medicines Recall | |
| 17th February 2022 | MHRA Class 2 Medicines Recall | |
| 15th February 2022 | MHRA Class 2 Medicines Recall | |
| 3rd February 2022 | Class 4 Medicines Defect Information | |
| 1st February 2022 | Class 4 Medicines Defect Information | |
| 31st January 2022 | Class 4 Medicines Defect Information |
Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion (Antibiotice SA) |
| 19th January 2022 | MHRA Class 2 Medicines Recall | |
| 8th December 2021 | MHRA Class 2 Medicines Recall | |
| 30th November 2021 | MHRA Class 2 Medicines Recall | |
| 29th November 2021 | MHRA Class 4 Medicines Defect Information | |
| 29th November 2021 | Class 4 Medicines Defect Information |
Diuril Oral Solution (unlicensed medicine) Mawdsley-Brooks & Company Limited |
| 15th November 2021 | MHRA Class 4 Medicines Defect Information | |
| 26th October 2021 | Class 3 Medicines Recall | |
| 14th October 2021 | Class 2 Medicines Recall | |
| 15th September 2021 | MHRA Class 2 Medicines Recall | |
| 10th September 2021 | MHRA Class 4 Medicines Defect Information |
Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets |
| 25th August 2021 | MHRA Class 2 Medicines Recall |
Metformin Hydrochloride 500mg/5ml Oral Solution (Rosemont Pharmaceuticals Limited) |
| 18th August 2021 | National Patient Safety Alert | |
| 9th August 2021 | MHRA Class 2 Medicines Recall | |
| 19th July 2021 | MHRA Class 4 Medicines Defect Information |
Amoxicillin 500 mg/ 5 ml Powder for oral suspension, (PL 25298/0248) |
| 12th July 2021 | MHRA Class 4 Medicines Defect Information |
Sevredol 10mg and 20mg tablets (PL 16950/0063, PL 16950/0064) |
| 6th July 2021 | MHRA Class 4 Medicines Defect Information | |
| 16th June 2021 | National Patient Safety Alert |
Co-codamol 30/500 Effervescent Tablets (Zentiva Pharma UK Ltd) |
| 20th May 2021 | MHRA Class 3 Medicines Recall | |
| 17th May 2021 | MHRA Class 2 Medicines Recall |
Bricanyl Injection, 0.5 mg/ml solution for injection or infusion |
| 4th May 2021 | MHRA Class 4 Medicines Defect Information | |
| 22nd April 2021 | MHRA Class 2 Medicines Recall | |
| 15th March 2021 | MHRA Class 3 Medicines Recall | |
| 3rd March 2021 | MHRA Class 3 Medicines Recall |
Easyhaler Salbutamol Sulfate 100 & 200micrograms per actuation |
| 17th February 2021 | MHRA Class 3 Medicines Recall | Clonidine hydrochloride 50micrograms/5ml oral solution |
| 16th February 2021 | MHRA Class 2 Medicines Recall | MidaBuc – Midazolam (as HCL) 10mg/mL Oromucosal Solution |
| 8th February 2021 | MHRA Class 2 Medicines Recall | Palexia 20mg/ml Oral Solution |
| 3rd February 2021 | MHRA Class 3 Medicines Recall | Kolanticon Gel 500ml (Intrapharm) |
| Date issued | Issue |
| 1st August 2017 | Epilim 100mg crushable tablets risk materials (Sanofi) |
- The Community Pharmacy Patient Safety Group has a number of resources which community pharmacy teams may find useful
- Joint resource which aims to support community pharmacy teams in helping women and girls who have been prescribed valproate medicines – includes a decision pathway and key points for consideration to prompt conversations between the pharmacy team and their patients.
- Company Chemists’ Association audit tool for community pharmacy teams to use in reviewing their support for girls and women taking valproate medicines.
For more information on this topic please email comms.team@cpe.org.uk
