Archive for MHRA Updates
Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
Source: MHRA 10.08.2026 The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK...
Belzer UW® Cold Storage Solution and Belzer MPS® (UW Machine Perfusion Solution): manufactured by Carnamedica (UKRP: Bridge to Life): Updated advice on the contamination of fluid DSI/2026/006 (update to DSI/2023/005)
Source: MHRA 06.08.2026 The MHRA is providing an update on defects previously identified with Belzer solutions for the preservation of donated organs. This DSI replaces advice in DSI/2023/005 Summary The...
Dräger Atlan Anaesthesia workstations: risk of ventilator failure (DSI/2026/005)
Source: MHRA 04.08.2026 In April 2026, Dräger issued a follow-up Field Safety Notice expanding the number of Atlan Anaesthesia workstation devices affected by a manufacturing defect that may result in...
Class 4 Medicines Defect Notification: Neuraxpharm UK Ltd, Tuzulby prolonged-release chewable tablets, EL(26)A/36
Source: MHRA 23.07.2026 Neuraxpharm UK Ltd has informed the MHRA of missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for certain batches of...
Class 4 Medicines Defect Notification: Macarthys Laboratories Ltd T/A Martindale Pharma, Xaggitin XL Prolonged-release Tablets, EL(26)A/35
Source: MHRA 20.07.2026 Macarthys Laboratories Ltd T/A Martindale Pharma has notified the MHRA of a manufacturing issue impacting several batches of Xaggitin XL Prolonged-release Tablets, due to the occurrence of...
Class 2 Medicines Recall: Beckton Dickson UK Ltd, ChloraPrep 1mL applicator, EL(26)A/34
Source: MHRA 13.07.2026 Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators due to a potential breach of sterility in the...
Class 2 Medicines Recall: Bristol Laboratories Limited, Phenoxymethylpenicillin 250 mg/5ml Sugar free Oral Solution BP, EL(26)A/33
Source: MHRA 09.07.2026 Bristol Laboratories Limited is recalling one batch (7124002) of Phenoxymethylpenicillin 250 mg/5 ml Oral Solution Sugar Free due to product labelling issues. DMRC reference number DMRC-40025785 Marketing...
UPDATE: Class 4 Medicines Defect Notification: Relonchem Limited, Gabapentin Relonchem 50mg/ml Oral Solution, EL(26)A/31
Source: MHRA 30.06.2026 – Updated 07.07.2026 Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint....
Class 3 Medicines Recall: Flamingo Pharma UK Ltd, Flucloxacillin Capsules BP 500mg, EL(26)A/32
Source: MHRA 30.06.2026 Flamingo Pharma UK Ltd have informed the MHRA that certain packs of Flucloxacillin Capsules BP 500mg contain the incorrect PIL. The affected packs contain the PIL for...
Class 4 Medicines Defect Notification: Relonchem Limited, Gabapentin Relonchem 50mg/ml Oral Solution, EL(26)A/31
Source: MHRA 30.06.2026 Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint. DMRC reference number...
Class 4 Medicines Defect Notification: Brancaster Pharma Limited, Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension for injection, EL(26)A/30
Source: MHRA 29.06.2026 Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an...
Class 3 Medicines Recall: Orbit Pharma Limited, Cyclizine Lactate 50 mg/ml Solution for injection, EL(26)A/29
Source: MHRA 16.06.26 Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies...
