← Alert archive

MHRA alerts issued in 2025

123 alerts.

• Field Safety Notices: 22-26 December 2025

  30 Dec 2025 · Field safety notice (devices)

• Field Safety Notices: 15 - 19 December 2025

  22 Dec 2025 · Field safety notice (devices)

• MHRA Safety Roundup: December 2025

  18 Dec 2025 · MHRA Safety Roundup

• Field Safety Notices: 8 - 12 December 2025

  15 Dec 2025 · Field safety notice (devices)

• Class 3 Medicines Recall: Activase Pharmaceuticals Limited, Prednisolone 5mg Soluble Tablets, EL(25)A/54

  15 Dec 2025 · Medicines recall/notification · EL (25)A/54

  Class 3
• Class 2 Medicines Recall: Hameln Pharma Ltd, Clarithromycin 500 mg powder for concentrate for solution for infusion, EL(25)A/53

  11 Dec 2025 · Medicines recall/notification · EL (25)A/53

  Class 2
• Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52

  10 Dec 2025 · Medicines recall/notification · EL (25)A/52

  Class 4
• Field Safety Notices: 1 to 5 December 2025

  8 Dec 2025 · Field safety notice (devices)

• Field Safety Notices: 24 to 28 November 2025

  2 Dec 2025 · Field safety notice (devices)

• MHRA Safety Roundup: November 2025

  27 Nov 2025 · MHRA Safety Roundup · EL (25)A/49

• Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51

  27 Nov 2025 · Medicines recall/notification · EL (25)A/51

  Class 4
• Field Safety Notices: 17 to 21 November 2025

  25 Nov 2025 · Field safety notice (devices)

• Class 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets, EL(25)A/50

  25 Nov 2025 · Medicines recall/notification · EL (25)A/50

  Class 4
• Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49

  20 Nov 2025 · Medicines recall/notification · EL (25)A/49

  Class 3
• Field Safety Notices: 10 to 14 November 2025

  18 Nov 2025 · Field safety notice (devices)

• Field Safety Notices: 3 to 7 November 2025

  11 Nov 2025 · Field safety notice (devices)

• Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48

  11 Nov 2025 · Medicines recall/notification · EL (25)A/48

  Class 3
• Class 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film, EL(25)A/47

  10 Nov 2025 · Medicines recall/notification · EL (25)A/47

  Class 3
• Field Safety Notices: 27 to 31 October 2025

  4 Nov 2025 · Field safety notice (devices)

• MHRA Safety Roundup: October 2025

  28 Oct 2025 · MHRA Safety Roundup

• Field Safety Notices: 20 to 24 October 2025

  28 Oct 2025 · Field safety notice (devices)

• Class 2 Medicines Recall: Baxter Healthcare Limited, Compound Sodium Lactate Solution for Infusion BP (Hartmann's Solution for infusion) in Viaflo 1000ml, EL(25)A/46

  28 Oct 2025 · Medicines recall/notification · EL (25)A/46

  Class 2
• Class 4 Medicines Defect Notification: Relonchem Ltd, Various Products, EL(25)A/44

  23 Oct 2025 · Medicines recall/notification · EL (25)A/44

  Class 4
• Class 3 Medicines Recall: Accord Healthcare Ltd, Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution, EL(25)A/45

  23 Oct 2025 · Medicines recall/notification · EL (25)A/45

  Class 3
• Field Safety Notices: 13 to 17 October 2025

  21 Oct 2025 · Field safety notice (devices)

• Field Safety Notices: 29 September to 3 October 2025

  7 Oct 2025 · Field safety notice (devices)

• Field Safety Notices: 6 October to 10 October 2025

  6 Oct 2025 · Field safety notice (devices)

• BD BodyComm™ version 3.3 software used for BodyGuard infusion pumps, BodyGuard-T and T34 syringe drivers: Important steps to manage transition to Windows 11 (DSI/2025/006)

  6 Oct 2025 · Device safety information

• MHRA Safety Roundup: September 2025

  30 Sept 2025 · MHRA Safety Roundup

• Field Safety Notices: 22 to 26 September 2025

  30 Sept 2025 · Field safety notice (devices)

• Field Safety Notices: 15 to 19 September 2025

  23 Sept 2025 · Field safety notice (devices)

• Field Safety Notices: 8 to 12 September 2025

  16 Sept 2025 · Field safety notice (devices)

• Field Safety Notices: 1 to 5 September 2025

  9 Sept 2025 · Field safety notice (devices)

• Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43

  4 Sept 2025 · Medicines recall/notification · EL (25)A/43

  Class 4
• Field Safety Notices: 25 to 29 August 2025

  2 Sept 2025 · Field safety notice (devices)

• MHRA Safety Roundup: August 2025

  28 Aug 2025 · MHRA Safety Roundup · EL (25)A/38

• Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)

  27 Aug 2025 · Device safety information

• Class 4 Medicines Defect Notification: Ipca Laboratories UK Limited, Various Products, EL(25)A/42

  26 Aug 2025 · Medicines recall/notification · EL (25)A/42

  Class 4
• Field Safety Notices: 18 to 22 August 2025

  22 Aug 2025 · Field safety notice (devices)

• Class 4 Medicines Defect Notification: Fexofenadine Hydrochloride 120mg film-coated tablets, Chanelle Medical Unlimited Company, EL(25)A/41

  21 Aug 2025 · Medicines recall/notification · EL (25)A/41

  Class 4
• Field Safety Notices: 11 to 15 August 2025

  18 Aug 2025 · Field safety notice (devices)

• Class 4 Medicines Defect Notification: Levetiracetam Accord 100mg/ml oral solution, Accord Healthcare Limited, UK, EL(25)A/40

  14 Aug 2025 · Medicines recall/notification · EL (25)A/40

  Class 4
• Field Safety Notices: 4 to 8 August 2025

  12 Aug 2025 · Field safety notice (devices)

• Class 4 Medicines Defect Notification: Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution, Zydus Pharmaceuticals UK Ltd, EL(25)A/39

  7 Aug 2025 · Medicines recall/notification · EL (25)A/39

  Class 4
• Field Safety Notices: 28 July to 1 August 2025

  5 Aug 2025 · Field safety notice (devices)

• Class 2 Medicines Recall: Fucidin 250 mg Tablets, LEO Laboratories Ltd trading as LEO Pharma, EL(25)A/38

  4 Aug 2025 · Medicines recall/notification · EL (25)A/38

  Class 2
• MHRA Safety Roundup: July 2025

  31 Jul 2025 · MHRA Safety Roundup

• Class 4 Medicines Defect Notification: Olmesartan medoxomil 10mg film-coated tablets, Jubilant Pharmaceuticals NV, EL(25)A/37

  31 Jul 2025 · Medicines recall/notification · EL (25)A/37

  Class 4
• Field Safety Notices: 21 to 25 July 2025

  29 Jul 2025 · Field safety notice (devices)

• Updated guidance on the management of the recalled Endologix Nellix EndoVascular Aneurysm Sealing (EVAS) System (DSI/2025/004)

  28 Jul 2025 · Device safety information

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

  28 Jul 2025 · Medicines recall/notification · EL (25)A/36

  Class 2
• Class 2 Medicines Recall: Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension , CD Pharma Ltd, EL(25)A/35

  24 Jul 2025 · Medicines recall/notification · EL (25)A/35

  Class 2
• Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus (DSI/2025/003)

  22 Jul 2025 · Device safety information

• Field Safety Notices: 14 to 18 July 2025

  22 Jul 2025 · Field safety notice (devices)

• Field Safety Notices: 7 to 11 July 2025

  15 Jul 2025 · Field safety notice (devices)

• Field Safety Notices: 30 June to 4 July 2025

  8 Jul 2025 · Field safety notice (devices)

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

  7 Jul 2025 · Medicines recall/notification · EL (25)A/34

  Class 2
• Class 4 Medicines Defect Notification: Simvastatin 10mg Tablet, Crescent Pharma Ltd, EL(25)A/33

  3 Jul 2025 · Medicines recall/notification · EL (25)A/33

  Class 4
• Field Safety Notices: 23 to 27 June 2025

  1 Jul 2025 · Field safety notice (devices)

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

  1 Jul 2025 · Medicines recall/notification · EL (25)A/32

  Class 4
• Aurum pre-filled syringes phased introduction of new 10ml CONNECT syringe barrel: Importance of selecting compatible needle-free connectors to minimise the risk of syringe blockage (DSI/2025/02)

  1 Jul 2025 · Device safety information

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

  30 Jun 2025 · Medicines recall/notification · EL (25)A/31

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

  30 Jun 2025 · Medicines recall/notification · EL (25)A/30

  Class 3
• Class 3 Medicines Recall: Kimmtrak 200 micrograms/mL concentrate for solution for infusion, Immunocore Limited, EL(25)A/28

  25 Jun 2025 · Medicines recall/notification · EL (25)A/28

  Class 3
• Class 2 Medicines Recall: Depo-Medrone 80 mg in 2 mL, Maxearn Limited EL(25)A/29

  25 Jun 2025 · Medicines recall/notification · EL (25)A/29

  Class 2
• MHRA Safety Roundup: June 2025

  24 Jun 2025 · MHRA Safety Roundup

• Field Safety Notices: 16 to 20 June 2025

  24 Jun 2025 · Field safety notice (devices)

• Field Safety Notices: 9 to 13 June 2025

  17 Jun 2025 · Field safety notice (devices)

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

  12 Jun 2025 · Medicines recall/notification · EL (25)A/27

  Class 2
• Field Safety Notices: 2 to 6 June 2025

  10 Jun 2025 · Field safety notice (devices)

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

  10 Jun 2025 · Medicines recall/notification · EL (25)A/26

  Class 4
• Class 2 Medicines Recall: Paracetamol 500mg Tablets, Chelonia Healthcare Limited, EL(25)A/25

  9 Jun 2025 · Medicines recall/notification · EL (25)A/25

  Class 2
• Field Safety Notices: 26 to 30 May 2025

  3 Jun 2025 · Field safety notice (devices)

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

  2 Jun 2025 · Medicines recall/notification · EL (25)A/24

  Class 4
• MHRA Safety Roundup: May 2025

  29 May 2025 · MHRA Safety Roundup

• Field Safety Notices: 19 to 23 May 2025

  27 May 2025 · Field safety notice (devices)

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

  22 May 2025 · Medicines recall/notification · EL (25)A/23

  Class 2
• Field Safety Notices: 12 to 16 May 2025

  20 May 2025 · Field safety notice (devices)

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

  19 May 2025 · Medicines recall/notification · EL (25)A/22

  Class 2
• Field Safety Notices: 5 to 9 May 2025

  13 May 2025 · Field safety notice (devices)

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

  13 May 2025 · Medicines recall/notification · EL (25)A/21

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

  8 May 2025 · Medicines recall/notification · EL (25)A/20

  Class 4
• Field Safety Notices: 28 April to 2 May 2025

  6 May 2025 · Field safety notice (devices)

• MHRA Safety Roundup: April 2025

  29 Apr 2025 · MHRA Safety Roundup

• Field Safety Notices: 21 to 25 April 2025

  29 Apr 2025 · Field safety notice (devices)

• Class 4 Medicines Defect Notification: Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules, Jubilant Pharmaceuticals NV, EL(25)A/19

  29 Apr 2025 · Medicines recall/notification · EL (25)A/19

  Class 4
• Class 4 Medicines Defect Notification: Brilique 90mg Tablets, EL(25)A/18

  24 Apr 2025 · Medicines recall/notification · EL (25)A/18

  Class 4
• Field Safety Notices: 14 to 18 April 2025

  22 Apr 2025 · Field safety notice (devices)

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

  17 Apr 2025 · Medicines recall/notification · EL (25)A/17

  Class 2
• Field Safety Notices: 7 to 11 April 2025

  15 Apr 2025 · Field safety notice (devices)

• Field Safety Notices: 31 March to 4 April 2025

  8 Apr 2025 · Field safety notice (devices)

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

  8 Apr 2025 · Medicines recall/notification · EL (25)A/16

  Class 2
• Class 4 Medicines Defect Notification: Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare NephroMed GmbH, EL(25)A15

  7 Apr 2025 · Medicines recall/notification

  Class 4
• Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution, EL(25)A/14

  2 Apr 2025 · Medicines recall/notification · EL (25)A/14

  Class 3
• Field Safety Notices: 24 to 28 March 2025

  1 Apr 2025 · Field safety notice (devices)

• Class 2 Medicines Recall: Utrogestan Vaginal 200 mg Capsules (progesterone), EL(25)A/13

  1 Apr 2025 · Medicines recall/notification · EL (25)A/13

  Class 2
• Class 4 Medicines Defect Notification: Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, EL(25)A/12

  31 Mar 2025 · Medicines recall/notification · EL (25)A/12

  Class 4
• MHRA Safety Roundup: March 2025

  25 Mar 2025 · MHRA Safety Roundup

• Field Safety Notices: 17 to 21 March 2025

  25 Mar 2025 · Field safety notice (devices)

• Suzhou Surgicare disposable Hysteroscopy Sheath– Recall due to withdrawn CE certificate, (DSI/2025/001)

  19 Mar 2025 · Device safety information

• Field Safety Notices: 10 to 14 March 2025

  18 Mar 2025 · Field safety notice (devices)

• Field Safety Notices: 3 to 7 March 2025

  11 Mar 2025 · Field safety notice (devices)

• UPDATE: Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11

  11 Mar 2025 · Medicines recall/notification · EL (25)A/11

  Class 4
• Field Safety Notices: 24 to 28 February 2025

  4 Mar 2025 · Field safety notice (devices)

• Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe B.V., Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/100ML (8mg/ml) Infusion bag, EL(25)A/09

  4 Mar 2025 · Medicines recall/notification · EL (25)A/09

  Class 2
• Class 2 Medicines Recall: Boots Paracetamol 500 mg tablets (16s), EL(25)A/10

  4 Mar 2025 · Medicines recall/notification · EL (25)A/10

  Class 2
• Class 3 Medicines Recall: Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection, EL(25)A/08

  3 Mar 2025 · Medicines recall/notification · EL (25)A/08

  Class 3
• Field Safety Notices: 17 to 21 February 2025

  25 Feb 2025 · Field safety notice (devices)

• Class 4 Medicines Defect Notification: Rayner Pharmaceuticals Limited, Dropodex 0.1% w/v Eye Drops, solution, EL(26)A/10

  24 Feb 2025 · Medicines recall/notification · EL (26)A/10

  Class 4
• Class 3 Medicines Recall: Glucophage SR 500 mg, 750mg and 1000mg Prolonged-release Tablets, EL(25)A/07

  20 Feb 2025 · Medicines recall/notification · EL (25)A/07

  Class 3
• Field Safety Notices: 3 to 7 February 2025

  11 Feb 2025 · Field safety notice (devices)

• Class 4 Medicines Notification: Lansoprazole Gastro-resistant Hard Capsules 15mg, EL(25)A/06

  11 Feb 2025 · Medicines recall/notification · EL (25)A/06

  Class 4
• Field Safety Notices: 10 to 14 February 2025

  10 Feb 2025 · Field safety notice (devices)

• Class 2 Medicines Recall: Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules, EL(25)A/05

  5 Feb 2025 · Medicines recall/notification · EL (25)A/05

  Class 2
• Field Safety Notices: 27 to 31 January 2025

  4 Feb 2025 · Field safety notice (devices)

• Class 2 Medicines Recall: Bristol Laboratories Limited, Amlodipine Bristol Lab 2.5 mg Tablets, EL (25)A/04

  30 Jan 2025 · Medicines recall/notification · EL (25)A/04

  Class 2
• Field Safety Notices: 20 to 24 January 2025

  28 Jan 2025 · Field safety notice (devices)

• Field Safety Notices: 13 to 17 January 2025

  25 Jan 2025 · Field safety notice (devices)

• UPDATE: Class 2 Medicines Recall: Tesco Health Dry Cough Relief 200ml, Asda Strong Dry Tickly Cough 200ml, Almus Dry Cough Relief & Bells Dual Action Dry Cough, EL(25)A/03

  22 Jan 2025 · Medicines recall/notification · EL (25)A/03

  Class 2
• M6-C Artificial Cervical Disc, Spinal Kinetics LLC: New monitoring requirements for the risk of osteolysis (DSI/2026/001)

  15 Jan 2025 · Device safety information

• Field Safety Notices: 6 to 10 January 2025

  14 Jan 2025 · Field safety notice (devices)

• Class 4 Medicines Notification: Irbesartan 150 mg and 300 mg film-coated tablets, EL(25)A/02

  13 Jan 2025 · Medicines recall/notification · EL (25)A/02

  Class 4
• Field Safety Notices: 30 December 2024 to 3 January 2025

  7 Jan 2025 · Field safety notice (devices)

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