Archive for MHRA Updates
Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02
Source: MHRA/Gov.uk 21.1.2026 Glenmark Pharmaceuticals Europe Limited is recalling one batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results...
Class 2 Medicines Recall: Mercury Pharmaceuticals Ltd, Paliperidone Mercury Pharma prolonged-release suspension for injection in pre-filled syringes, EL(26)A/01
Source: MHRA/Gov.uk 20.01.2026 Mercury Pharmaceuticals Ltd is recalling remaining stock of paliperidone pre-filled syringes as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies cited during a recent...
M6-C Artificial Cervical Disc, Spinal Kinetics LLC: New monitoring requirements for the risk of osteolysis (DSI/2026/001)
Source: MHRA/Gov.uk 15.1.2026 The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is issuing new monitoring requirements for patients implanted with...
Class 3 Medicines Recall: Activase Pharmaceuticals Limited, Prednisolone 5mg Soluble Tablets, EL(25)A/54
Source: MHRA/ Gov.uk 15.12.25 Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets...
Class 2 Medicines Recall: Hameln Pharma Ltd, Clarithromycin 500 mg powder for concentrate for solution for infusion, EL(25)A/53
Source: MHRA/ Gov.uk 11.12.25 Hameln Pharma Ltd is recalling certain batches of Clarithromycin 500 mg powder for concentrate for solution for infusion. DMRC reference number DMRC-37790612 Marketing Authorisation Holder Hameln...
Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52
Source: MHRA/ Gov.uk 10.12.25 Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the...
Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51
Source: MHRA/ Gov.uk 27.11.25 Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the...
Class 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets, EL(25)A/50
Source: MHRA/ Gov.uk 25.11.25 Lexon UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification is missing important...
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49
Source: MHRA/Gov.uk 20.11.2025 Sun Pharma UK Limited is conducting a precautionary recall of a single batch of Fingolimod SUN 0.5 mg hard capsules due to reports of capsule breakage on...
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48
Source: MHRA 11.11.25 Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing...
Class 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film, EL(25)A/47
Source: MHRA 10.11.25 Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing. DMRC reference number...
Class 4 Medicines Defect Notification: Relonchem Ltd, Various Products, EL(25)A/44
Source: MHRA/Gov.uk 23.10.2025 Relonchem Ltd has informed the MHRA that duplicate GTIN numbers have been assigned to certain Losartan potassium/Hydrochlorothiazide coated tablets in error and a duplicate EAN number has...
