Patient safety information

Published on: 27th July 2017 | Updated on: 26th February 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 These have now been replaced by ‘Medicines recall/notification’, which will have the same layout and format as previous ‘alerts’.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.

Medicines recall/notification & National Patient Safety Alerts (NatPSA)
Date issued Recall/Notification type Medicines recall/notification
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

Loceryl 5% w/v Medicated Nail Lacquer

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

Oxycodone Hydrochloride 10mg/ml oral solution

21st November 2022 MHRA Class 4 Medicines Defect Information

Hyoscine Butylbromide 20 mg film-coated tablets

16th November 2022 MHRA Class 4 Medicines Defect Information

Venlafaxine XL 300 mg prolonged-release tablets

27th October 2022 MHRA Class 3 Medicines Recall

Mebeverine hydrochloride 135mg Film-coated tablets

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

Ephedrine Hydrochloride 30 mg/ml Solution for Injection

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

Sandimmun Oral Solution

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

Dysport 500 Units Powder for Solution for Injection

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

OxyContin 20 mg prolonged release tablets

17th May 2022 MHRA Class 2 Medicines Recall

Mefenamic Acid 500mg film coated tablets

5th May 2022 MHRA Class 2 Medicines Recall

Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets

27th April 2022 MHRA Class 2 Medicines Recall

Paroxetine 40mg Film Coated Tablets

11th April 2022 MHRA Class 2 Medicines Recall

Olopatadine USV 1mg/ml Eye Drops

28th March 2022 MHRA Class 2 Medicines Recall

Accuretic 10/12.5 mg film-coated tablets

15th March 2022 MHRA Class 4 Medicines Defect Information

Beclometasone dipropionate 50 micrograms/dose Nasal Spray

14th March 2022 MHRA Class 4 Medicines Defect Information

Latuda film-coated tablets

7th March 2022  MHRA Class 2 Medicines Recall

Diazepam RecTubes 2.5mg Rectal Solution

2nd March 2022 MHRA Class 3 Medicines Recall

Isotard 60mg XL Tablets

17th February 2022 MHRA Class 2 Medicines Recall

Efudix 5% Cream

15th February 2022 MHRA Class 2 Medicines Recall

Water for Injections BP – 100ml vial

3rd February 2022 Class 4 Medicines Defect Information

Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets (Atnahs Pharma UK Limited)

1st February 2022 Class 4 Medicines Defect Information

Ibuprofen 400mg tablets

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

Ikervis 1mg/ml eye drops

8th December 2021 MHRA Class 2 Medicines Recall

Mydrilate 0.5% Eye Drops 5ml

30th November 2021 MHRA Class 2 Medicines Recall

Irbesartan containing products

29th November 2021 MHRA Class 4 Medicines Defect Information

Mometasone Furoate 50 microgram/Dose Nasal Spray

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

Slenyto 1 mg and 5mg prolonged-release tablets

26th October 2021 Class 3 Medicines Recall

 Bimatoprost 0.3mg/ml eye drops

14th October 2021 Class 2 Medicines Recall

Champix (all strengths) film-coated tablets (Pfizer Ltd)

15th September 2021  MHRA Class 2 Medicines Recall

Ikervis 1mg/ml eye drops

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

Synthetic Opioids

9th August 2021 MHRA Class 2 Medicines Recall

Irbesartan containing products

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

Tetralysal 300mg Hard Capsules (PL 10590/0019)

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

Carbimazole 10mg and 15mg tablets

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

Syonell 250mg & 500mg gastro-resistant tablets

22nd April 2021 MHRA Class 2 Medicines Recall

Trimethoprim 200mg tablets (Ennogen)

15th March 2021 MHRA Class 3 Medicines Recall

Itraconazole 10mg/ml oral solution

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)

MHRA drug safety update
Manufacturers' resources
Date issued Issue
1st August 2017 Epilim 100mg crushable tablets risk materials (Sanofi)

Other resources
  • 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.

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